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Suggestions within category "Heart & Vascular"


34 Study Matches

Electrophysiology of Fetal Arrhythmia (fMCG)

Fetal research and clinical practice has been hampered by a lack of suitable investigational techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy and physiology, but it has significant limitations for assessment of cardiac rhythm. The proposed study will allow the investigators to evaluate fetal magnetocardiography (fMCG) as a new tool for the study of normal and abnormal fetal heart rate and rhythm.
Ronald Wakai, PhD
Female
18 Years and over
NA
This study is also accepting healthy volunteers
NCT03047161
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Inclusion Criteria:

• uncomplicated pregnancy at gestational age >12 weeks
• pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age >15 weeks
Exclusion Criteria:

• uncomplicated pregnancy <12 weeks gestation
• pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age <15 weeks
Supervision of high risk pregnancy, Healthy Volunteers, Fetal Arrhythmia
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Carotid Atherosclerotic Plaque Study

First, to establish a comparison of the pathophysiology of carotid atherosclerosis and the genetic and environmental variables that cause those plaques to become symptomatic. Second, to differentiate between vulnerable plaque and other types of plaque using ultrasound elastography, MRI data, trans-cranial doppler along with RF (radio frequency) analysis of back-scattered ultrasonic echoes.
Robert Dempsey, MD
All
18 Years to 80 Years old
NA
This study is NOT accepting healthy volunteers
NCT00214006
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Inclusion Criteria:

• Male and Female patients aged 18-80 presenting for carotid endarterectomy
Exclusion Criteria:

• Patients not felt suitable for carotid endarterectomy and those with impaired decision-making capacity
Carotid artery syndrome (hemispheric), Atherosclerosis, Brain & Neurological
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NAN-101 in Patients With Class III Heart Failure (NAN-CS101)

This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of BNP116.sc-CMV.I1c in patients with NYHA Class III heart failure. Patients with symptomatic congestive heart failure will be enrolled until up to 12 subjects have received infusions of investigational product. All patients will be followed until 12 months post treatment intervention, and then undergo long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).
David Murray, MD
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04179643
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Inclusion criteria:
• Age >18 years of age
• Chronic non-ischemic cardiomyopathy
• LVEF ≤ 30% by transthoracic echocardiography (TTE) within 6 months prior to enrollment
• NYHA Class III HF for a minimum of 6 months HF despite appropriate medical therapy (defined below):
• Treatment with appropriate HF therapy as tolerated, including, but not limited to:
• Beta blocker therapy and angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or sacubitril/valsartan combination therapy (Entresto) for ≥ 90 days prior to enrollment. May also receive aldosterone antagonist therapy. Doses of the above medications must be stable for ≥ 30 days prior to enrollment; and
• Cardiac resynchronization therapy (CRT), if clinically indicated, must have been implanted ≥ 90 days prior to enrollment. Internal cardioverter defibrillator (ICD) must be implanted, if clinically indicated ≥ 30 days prior to enrollment
• Females of childbearing potential must use at least one of the following acceptable birth control methods throughout the study and for 6 months after IP administration:
• Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum prior to IP administration
• Intrauterine device in place for at least 90 days prior to receiving IP
• Barrier methods (diaphragm plus spermicide or condom) starting at least 30 days prior to receiving IP
• Abstinence (the subject must be willing to remain abstinent from screening to 6 months after receiving IP). Females are allowed to claim abstinence as their method of contraception only when it is the preferred and usual lifestyle of the subject
• Surgical sterilization of the partner(s) (vasectomy) for >180 days prior to IP administration
• Hormonal contraceptives starting > 90 days prior to IP. If hormonal contraceptives are started less than 90 days prior to receiving IP, subjects must agree to use a barrier method (diaphragm plus spermicide or condom) from screening through 90 days after initiation of hormonal contraceptives
• Males subjects capable of fathering a child:
• Must agree to use a condom from IP administration through 6 months after the time of IP administration
• Must agree not to donate sperm for 6 months after time of receiving IP
• Documented evidence of vasectomy in males for 180 days minimum prior to receiving IP is an acceptable form of contraception
• Males who claim abstinence as their method of contraception are allowed provided they agree to use barrier methods should they become sexually active from screening through 6 months after receiving IP. Males are allowed to claim abstinence as their method of contraception only when it is the preferred and usual lifestyle of the subject
• Ability to sign Informed Consent Form (ICF) and Release of Medical Information Form
• Appropriate candidate for protocol-specified intracoronary infusion in the judgment of the infusing interventional cardiologist
Exclusion Criteria:

• Chronic ischemic cardiomyopathy
• Intravenous (IV) inotropic therapy, intra-aortic balloon pump (IABP) or percutaneous cardiac assist device therapy within 30 days prior to enrollment
• Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic LV aneurysm
• Cardiac surgery or percutaneous coronary intervention (PCI) within 30 days prior to enrollment
• Third degree heart block
• Clinically significant myocardial infarction (MI) in the judgment of the subject's physician (e.g., ST elevation MI [STEMI] or large non-STEMI) within 6 months prior to enrollment
• Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), surgically implanted LVAD or cardiac shunt
• Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LV reduction surgery, heart transplant, conventional revascularization procedure, or valvular repair within 3 months of IP dosing
• Known hypersensitivity to contrast dyes used for angiography; history of, or likely need for, high-dose steroid pretreatment prior to contrast angiography
• Expected survival < 1 year in the judgment of the investigator
• Active or suspected infection within 48 hours prior to enrollment as evidenced by fever or positive culture
• Known intrinsic liver disease (e.g., cirrhosis, hepatitis A, chronic hepatitis B or hepatitis C virus infection). If serology is positive and PCR is negative, subject may be eligible (confirm with medical monitor).
• Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase) > 2x upper limit of normal (ULN) within 30 days prior to enrollment.
• Renal Failure, dialysis dependent or serum creatinine > 2.5 mg/dl within 30 days prior to enrollment
• Bleeding diathesis or thrombocytopenia defined as platelets <50,000 platelets/μL within 30 days prior to enrollment
• Anemia defined as hemoglobin <10 g/dL or transfusion dependent within 30 days prior to enrollment
• Neutropenia defined as absolute neutrophils <1500 mm3 within 30 days prior to enrollment
• Known AIDS or HIV-positive status, or a previous diagnosis of immunodeficiency with an absolute neutrophil count <1000 cells/mm3
• Previous participation in a study of gene transfer
• Receiving investigational intervention or participating in another clinical study within 30 days or within 5 half-lives of another investigational drug administration prior to administration of NAN-101 that may impact the therapeutic potential of NAN-101.
• Pregnancy or breastfeeding at the time of screening
Congestive Heart Failure, Heart Failure, Heart Disease, Ischemic, Cardiovascular Diseases, Heart Failure, Systolic, Heart Failure,Congestive, Heart Arrhythmia, Heart Failure, Diastolic, Heart, Complications, Cardiomyopathy, Heart & Vascular
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Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (POPS or POP02)

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
Maria Stanley
All
up to 20 Years old
NA
This study is also accepting healthy volunteers
NCT04278404
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Inclusion Criteria:
1. Participant is < 21 years of age 2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA: 3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment
Exclusion Criteria:
1. Participant has a known pregnancy Below exclusion criteria apply only to participants receiving one or more of the study drugs of interest at the time of enrollment, 2. Has had intermittent dialysis within previous 24 hours 3. Has had a kidney transplant within previous 30 days 4. Has had a liver transplant within previous 1 year 5. Has had a stem cell transplant within previous 1 year 6. Has had therapeutic hypothermia within previous 24 hours 7. Has had plasmapheresis within the previous 24 hours 8. Has a Ventricular Assist Device 9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Hemophilia, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis, Hemorrhage, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome
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Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG (PACES)

The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.
Satoru Osaki
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT04045665
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Inclusion Criteria:

• Patients of age ≥18 years who undergo isolated CABG for coronary artery disease
• POAF that persists for >60 minutes or is recurrent (more than one episode) within 7 days after the index CABG surgery
Exclusion Criteria:

• Clinical history of either permanent, persistent or paroxysmal atrial fibrillation
• Any pre-existing clinical indication for long-term OAC
• Any absolute contraindication to OAC
• Planned use of post-operative dual antiplatelet therapy (DAPT) a. This includes, but is not limited to, patients with recent PCI with drug-eluting or bare-metal stent.
• Cardiogenic shock
• Major perioperative complication* occurring between CABG and randomization a. Including stroke, TIA, MI, major bleeding (BARC type 4 bleeding), severe sepsis, renal failure requiring dialysis, or need for reoperation due to bleeding (e.g. pericardial tamponade).
• Concomitant left atrial appendage closure during CABG
• Concomitant valve surgery during CABG (including aortic, mitral, tricuspid or pulmonary)
• Concomitant or prior surgery for AF during CABG
• Closure of an atrial septal defect or of a patent foramen ovale during CABG
• Liver cirrhosis or Child-Pugh Class C chronic liver disease
• Pharmacologic therapy with an investigational drug or device within 30-days prior to randomization or plan to enroll patient in an investigational drug or device trial during participation in this trial
• Pregnancy at the time of randomization
• Unable or unwilling to provide inform consent
• Unable or unwilling to comply with the study treatment and follow-up
• Existence of underlying disease that limits life expectancy to less than one year
Atrial Fibrillation, Stroke, Bleeding, Cardiomyopathy, Heart & Vascular
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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)

Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.
Jon Matsumura, MD
All
35 Years to 100 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02089217
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General Inclusion Criteria 1. Patients ≥35 years old. 2. Carotid stenosis defined as:
• Stenosis ≥70% by catheter angiography (NASCET Criteria); OR
• by DUS with ≥70% stenosis defined by a peak systolic velocity of at least 230 cm/s plus at least one of the following: 1. an end diastolic velocity ≥100 cm/s, or 2. internal carotid/common carotid artery peak systolic velocity ratio ≥4.0, or 3. CTA with ≥ 70% stenosis, or 4. MRA with ≥ 70% stenosis. 3. No medical history of stroke or TIA ipsilateral to the stenosis within 180 days of randomization. Life-long asymptomatic patients will be defined as having no medical history of stroke or transient ischemic attack and negative responses to all of the symptom items on the Questionnaire for Verifying Stroke-free Status (QVSS).18 4. Patients must have a modified Rankin Scale score of 0 or 1 at the time of informed consent. 5. Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization. 6. Patients must agree to comply with all protocol-specified follow-up appointments. 7. Patients must sign a consent form that has been approved by the local governing Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site. 8. Randomization to treatment group will apply to only one carotid artery for patients with bilateral carotid stenosis. Management of the non-randomized stenosis may be done in accordance with local PI recommendation. Treatment of the non-study internal carotid artery must take place at least 30 days prior to randomization, or greater than 44 days after randomization and 30 days after the study procedure is completed (whichever is longer). 9. Carotid stenosis must be treatable with CEA, CAS, or either procedure. General Exclusion Criteria 1. Intolerance or allergic reaction to a study medication without a suitable management alternative. 2. GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy. 3. Prior major ipsilateral stroke in the past with substantial residual disability (mRS ≥ 2) that is likely to confound study outcomes. 4. Severe dementia. 5. History of major symptomatic intracranial hemorrhage within 12 months that was not related to anticoagulation. 6. Prior Intracranial hemorrhage that the investigator believes represents a contraindication to the perioperative or periprocedural antithrombotic and antiplatelet treatments necessary to complete endarterectomy or stenting per protocol. 7. Current neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke. 8. Patient objects to future blood transfusions. 9. Platelet count <100,000/microliter or history of heparin-induced thrombocytopenia. 10. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents. 11. Chronic atrial fibrillation. 12. Any episode of atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation that is deemed to require chronic anticoagulation. 13. Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired PFO with prior paradoxical embolism. 14. Unstable angina defined as rest angina with ECG changes that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization). 15. Left Ventricular Ejection fraction <30% or admission for heart failure in prior 6 months. 16. Respiratory insufficiency with life expectancy < 4 years or FEV1 <30% of predicted value. 17. Known malignancy other than basal cell non-melanoma skin cancer. There are two exceptions to this rule: patients with prior cancer treatment and no recurrence for >5 years are eligible for enrollment and cancer patients with life expectancy of greater than 5 years are eligible for enrollment. 18. Any major surgery, major trauma, revascularization procedure, or acute coronary syndrome within the past 1 month. 19. Either the serum creatinine is ≥ 2.5 mg/dl or the estimated GFR is < 30 cc/min. 20. Major (non-carotid) surgery/procedures planned within 3 months after enrollment. 21. Currently listed or being evaluated for major organ transplantation (i.e. heart, lung, liver, kidney). 22. Actively participating in another drug or aortic arch or cerebrovascular device trial for which participation in CREST-2 would be compromised with regard to follow-up assessment of outcomes or continuation in CREST-2. 23. Inability to understand and cooperate with study procedures or provide informed consent. 24. Non-atherosclerotic carotid stenosis (dissection, fibromuscular dysplasia, or stenosis following radiation therapy). 25. Previous ipsilateral CEA or CAS. 26. Ipsilateral internal or common carotid artery occlusion. 27. Intra-carotid floating thrombus. 28. Ipsilateral intracranial aneurysm > 5 mm. 29. Extreme morbid obesity that would compromise patient safety during the procedure or would compromise patient safety during the periprocedural period. 30. Coronary artery disease with two or more proximal or major diseased coronary arteries with 70% stenosis that have not, or cannot, be revascularized. Specific carotid endarterectomy exclusion criteria Patients who are being considered for revascularization by CEA must not have any of the following criteria: 1. Serious adverse reaction to anesthesia not able to be overcome by pre-medication. 2. Distal/intracranial stenosis greater than index lesion. 3. Any of the following anatomical: radical neck dissection; surgically inaccessible lesions (e.g. above cervical spine level 2 (C2)); adverse neck anatomy that limits surgical exposure (e.g. spinal immobility
•inability to flex neck beyond neutral or kyphotic deformity, or short obese neck); presence of tracheostomy stoma; laryngeal nerve palsy contralateral to target vessel; or previous extracranial-intracranial or subclavian bypass procedure ipsilateral to the target vessel. Specific Carotid Artery Stenting Exclusion Criteria Patients who are being considered for revascularization by CAS must not have any of the following criteria: 1. Allergy to intravascular contrast dye not amenable to pre-medication. 2. Type III, aortic arch anatomy. 3. Angulation or tortuosity (≥ 90 degree) of the innominate and common carotid artery that precludes safe, expeditious sheath placement or that will transmit a severe loop to the internal carotid after sheath placement. 4. Severe angulation or tortuosity of the internal carotid artery (including calyceal origin from the carotid bifurcation) that precludes safe deployment of embolic protection device or stent. Severe tortuosity is defined as 2 or more ≥ 90 degree angles within 4 cm of the target stenosis. 5. Proximal/ostial CCA, innominate stenosis or distal/intracranial stenosis greater than index lesion. Excessive circumferential calcification of the stenotic lesion defined as >3mm thickness of calcification seen in orthogonal views on fluoroscopy.(Note: Anatomic considerations such as tortuosity, arch anatomy, and calcification must be evaluated even more carefully in elderly subjects (≥ 70 years).) 6. Target ICA vessel reference diameter <4.0 mm or >9.0 mm. Target ICA measurements may be made from angiography of the contralateral artery. The reference diameter must be appropriate for the devices to be used. 7. Inability to deploy or utilize an FDA-approved Embolic Protection Device (EPD). 8. Non-contiguous lesions and long lesions (>3 cm). 9. Qualitative characteristics of stenosis and stenosis-length of the carotid bifurcation (common carotid) and/or ipsilateral external carotid artery, that preclude safe sheath placement. 10. Occlusive or critical ilio-femoral disease including severe tortuosity or stenosis that necessitates additional endovascular procedures to facilitate access to the aortic arch or that prevents safe and expeditious femoral access to the aortic arch. "String sign" of the ipsilateral common or internal carotid artery. 11. Angiographic, CT, MR or ultrasound evidence of severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries that would preclude safe passage of the sheath and other endovascular devices to the target artery as needed for carotid stenting.
Vascular Diseases [C14], Heart & Vascular, Carotid Stenosis
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AMPLATZER PFO Occluder Post Approval Study (PFO PAS)

The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
Kurt Jacobson, MD, MHSA
All
18 Years to 60 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03309332
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Inclusion Criteria:
• Subjects with a PFO who have had an ischemic stroke within the last 547 days
Exclusion Criteria:

• Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥ 50% lumen diameter supplying the involved lesion
• Intra-cardiac thrombus or tumor
• Documented evidence of venous thrombus in the vessels through which access to the PFO is gained
• Acute or recent (within 6 months prior to consent) myocardial infarction or unstable angina
• Left ventricular aneurysm or akinesis
• Mitral valve stenosis or severe mitral regurgitation requiring intervention irrespective of etiology
• Aortic valve stenosis (mean gradient >40 mmHg) or severe aortic valve regurgitation
• Mitral or aortic valve vegetation or prosthesis
• Aortic arch plaques protruding greater than 4mm into the aortic lumen
• Left ventricular dilated cardiomyopathy with depressed left ventricular ejection fraction (LVEF less than 35%)
• Subjects with other source of right to left shunts, including an atrial septal defect and/or fenestrated septum
• Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
• Pregnancy at the time of implant
• Age less than 18 years or greater than 60 years at time of consent
• Active endocarditis or other untreated infections
• Organ failure (kidney, liver or lung) Kidney failure: Poor urine output of less than 1 cc/kg/hr with elevated BUN levels (above the normal reference range for the laboratory at the investigational site). Liver failure: Liver enzymes outside the normal reference range for the laboratory at the investigational site: poor liver function as assessed by elevated PT (above the normal reference range for the laboratory at the investigational site) and low total protein and albumin (below the normal reference range for the laboratory at the investigational site). Lung failure: Respiratory failure is retention of carbon dioxide more than 60 mmHg, poor oxygenation with oxygen tension less than 40 mmHg in room air or the need for assisted ventilation.
• Uncontrolled hypertension defined as sustained elevated systemic blood pressure to more than 160/90 mmHg with medications
• Uncontrolled diabetes defined as continued elevated glucose levels in spite of administration of insulin/levels of more than 200 mg with presence of glucose in the urine
• Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying stroke event Definition: Ischemic stroke in the distribution of a single, small deep penetrating vessel in a patient with any of the following: 1) a history of hypertension (except in the first week post stroke); 2) history of diabetes mellitus; 3) Age >/= 50; or 4) MRI or CT shows leukoaraiosis greater than symmetric, well-defined periventricular caps or bands (European Task Force on Age-Related White Matter Changes rating scale score > 0)
• Arterial dissection as cause of stroke
• Subjects who test positive with one of the following hypercoagulable states; Anticardiolipin Ab of the IgG or IgM (≥30), Lupus anticoagulant, B2-glycoprotein-1 antibodies (≥30) or persistently elevated homocysteine (>20)
• Unable to take antiplatelet therapy
• Anatomy in which the AMPLATZERTM PFO Occluder device size required would interfere with intracardiac or intravascular structures such as valves or pulmonary veins
• Vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size
• Malignancy or other illness where life expectancy is less than 2 years
• Subjects who will not be available for follow-up for the duration of the trial
• Inability to obtain Informed Consent from patient
• Index stroke of poor outcome (modified Rankin score greater than 3)
Stroke, Patent Foramen Ovale, Cerebral infarction, Atrial septal defect, Heart & Vascular, Brain & Neurological
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Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 0/1) (SSB 11-02)

The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.
Kyla Bennett, MD
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02777528
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Inclusion Criteria:
1. Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2. 2. Age ≥18 years at time of informed consent signature 3. Subject is capable of complying with protocol requirements, including follow-up 4. Informed Consent Form (ICF) is signed by Subject or legal representative 5. Must have appropriate proximal aortic landing zone. 6. Must have appropriate target branch vessel landing zone. 7. For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone. 8. Native aortic valve (Zone 0/1 subjects only) 9. Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator (Zone 0/1 subjects only)
Exclusion Criteria:
1. Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair 2. Previous endovascular repair of the ascending aorta 3. Previous endovascular repair of the DTA with a non-Gore device 4. Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access. 5. Infected aorta 6. Life expectancy <2 years 7. Myocardial infarction within 6 weeks prior to treatment 8. Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin. 9. Patient has a systemic infection and may be at increased risk of endovascular graft infection 10. Pregnant female at time of informed consent signature 11. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome 12. Participation in another drug or medical device study within one year of study enrollment 13. Known history of drug abuse within one year of treatment 14. Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta 15. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access 16. Planned coverage of celiac artery 17. Patient has known sensitivities or allergies to the device materials 18. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment 19. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin 20. Patient with a history of a hypercoagulability disorder and/or hypercoagulability state 21. Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper 22. Mycotic aneurysm 23. Persistent refractory shock (systolic blood pressure <90 mm Hg) 24. Patient has body habitus or other medical condition which prevents adequate visualization of the aorta 25. Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis 26. Patient at high risk of neurological event, e.g. stroke
Aortic Aneurysm, Thoracic, Aorta, Lesion, Vascular Diseases [C14], Abdominal aortic aneurysm, without rupture, Heart & Vascular
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Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.
Paul Dimusto
All
21 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02489539
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Inclusion Criteria:
1. AAA meeting any of the following criteria:
• Maximum diameter ≥50 mm
• Rapid growth (>5 mm in a 6 month period)
• Non-ruptured AAA presenting with clinical symptoms 2. Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis, including:
• Adequate iliac / femoral access
• Infrarenal aortic neck diameter 16-32 mm
• Infrarenal aortic neck length ≥10 mm
• Aortic neck angle ≤ 90˚
• Distal iliac artery seal zone ≥10 mm
• Iliac artery diameter 8-25 mm 3. An Informed Consent Form (ICF) signed by Subject 4. Male or infertile female 5. Able to comply with Protocol requirements including following-up 6. Life expectancy > 2 years 7. Age ≥ 21 years
Exclusion Criteria:
1. Mycotic or ruptured aneurysm 2. Known concomitant thoracic aortic aneurysm which requires surgical intervention 3. Renal insufficiency defined as creatinine > 2.5 mg/dL or patient undergoing dialysis 4. New York Heart Association (NYHA) class IV 5. Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s) 6. Severely tortuous or stenotic iliac and / or femoral arteries 7. Patient has body habitus or other medical condition which prevents adequate delineation of the aorta 8. Participating in another investigational device or drug study within 1 year of treatment 9. Systemic infection which may increase the risk of endovascular graft infection 10. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome 11. Planned concomitant surgical procedure or major surgery within 30 days of treatment date 12. Known history of drug abuse 13. Known sensitivities or allergies to the device materials
Aortic Aneurysm, Abdominal, Vascular Diseases [C14], Heart & Vascular
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CardiAMP™ Cell Therapy Heart Failure Trial

This is a prospective, multi-center, randomized (3 Treatment : 2 Sham Control), sham-controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham treatment. A roll-in phase with a maximum of 10 subjects may occur.
Amish Raval, MD
All
21 Years to 90 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02438306
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Inclusion Criteria:

• New York Heart Association (NYHA) Class II or III
• A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI).
• On stable evidence-based medical and device therapy for heart failure or post-infarction left ventricular dysfunction, per the 2013 ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
• Left ventricular ejection fraction between 20% and 40%.
• Qualification of a pre-procedure screening of bone-marrow aspiration
Exclusion Criteria:
• Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
Heart Failure, Systolic (congestive) heart failure, Heart & Vascular
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Chronic Hypertension and Pregnancy (CHAP) Project (CHAP)

The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe.
Kara Hoppe
Female
12 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT02299414
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Inclusion Criteria:
1. Women with chronic hypertension in pregnancy with new or untreated chronic hypertension, blood pressure 140-159 systolic or 90-104 diastolic OR known chronic hypertension on monotherapy and taking any antihypertensive and blood pressure ≤159/104 (including those with blood pressure <140/90); 2. Singleton; and 3. viable pregnancy <23 weeks of gestation.
Exclusion Criteria:
1. Blood pressures prior to randomization ≥160 systolic or ≥105 diastolic (with or without treatment); 2. Severe hypertension including patients currently treated with >1 antihypertensive medication (more likely to have severe chronic hypertension); 3. Multi-fetal pregnancy; 4. Known secondary cause of chronic hypertension; 5. High-risk co-morbidities for which treatment may be indicated:
• Diabetes mellitus diagnosed at age ≤10 years or duration of diagnosis ≥20 years
• Diabetes mellitus complicated by end organ damage (retinopathy, nephropathy, heart disease, transplant)
• Chronic kidney disease
•including baseline proteinuria (>300mg/24-hr, protein/creatinine ratio ≥0.3, or persistent 1+ proteinuria*) or creatinine >1.2. *If a dipstick value at screening is more than trace, a clean catch or catheter urine should be obtained and re-tested by dipstick. If this shows trace or absence of protein, the patient is included. If it again shows 1+ protein, the patient is excluded until a 24-hr urine <300mg/24hr or p/c ratio is <0.3. If a p/c ratio is >0.3, the patient may be included if a 24-hour urine is < 300 mg.
• Cardiac disorders: cardiomyopathy, angina, CAD
• Prior stroke
• Retinopathy
• Sickle cell disease 6. Known major fetal anomaly; 7. Known fetal demise; 8. Suspected IUGR; 9. Membrane rupture or planned termination prior to randomization; 10. Plan to deliver outside the consortium centers (unless approved by the Clinical Coordinating Center) or unlikely to follow-up in the opinion of study staff or previous participation in this trial; 11. Contraindication to labetalol and nifedipine (e.g. know hypersensitivity); 12. Current substance abuse or addiction (cocaine, methamphetamine) 13. Participation in another trial without prior approval (CHAP participants will not be enrolled in other trials without prior approval by protocol committee) 14. Physician or provider refusal 15. Patient refusal *The minimum age varies by center
Hypertension, Pre-existing hypertension complicating pregnancy, childbirth and the puerperium
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ANTHEM-HFrEF Pivotal Study

A multi-center randomized controlled clinical trial to evaluate Autonomic Regulation Therapy with the VITARIA system in patients with symptomatic heart failure and reduced ejection fraction.
Ravi Dhingra
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03425422
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Inclusion Criteria:
1. Age 18 or above 2. Willing and capable of providing informed consent 3. Capable of participating in all testing associated with this clinical investigation 4. Stable, guideline-directed medical therapy for at least 4 weeks before subject screening. Unrestricted changes in diuretics are allowed during the 4 weeks, as long as the subject remains on a diuretic. If the use of an ARNI is being contemplated for a study subject, ARNI should be administered, and GDMT optimized, before the subject is randomized. No more than a 100% increase or 50% decrease of the dosage of any medication other than a diuretic is permitted. For these medications, medication changes within a class are allowed, as long as the equivalent dosage is within these specified limits 5. Stable symptomatic heart failure NYHA class III; or NYHA class II with a heart failure hospitalization in the previous 12 months. HF hospitalization may include an overnight hospital or hospital-based observation unit stay with a primary diagnosis of HF, or an emergency department visit with a primary diagnosis of HF, and will in either case include documentation of intravenous HF therapy administration or other intervention for HF 6. Left ventricular ejection fraction (EF) ≤ 35% and left ventricular end-diastolic diameter (LVEDD) < 8.0 cm, as confirmed by the core echocardiography laboratory during screening 7. N-terminal pro-BNP (NT-proBNP) level of at least 800 pg/mL, as determined by the core laboratory; or NT-proBNP level of at least 1200 pg/mL, as determined by the core laboratory, for patients with permanent atrial fibrillation or reporting signs or symptoms of atrial fibrillation at the time that the NT-proBNP sample is drawn 8. Received a standard cardiac assessment, including history, physical exam, and electrocardiogram, and determined by a heart failure cardiologist and study surgeon to be an appropriate candidate for the study's surgical procedure 9. Physically capable and willing to perform repeated 6-minute walk tests associated with the study, and having a baseline distance of between 150 and 450 meters. Symptoms limiting the duration of the 6 minute walk test must be due primarily to heart failure
Exclusion Criteria:
1. Refractory symptomatic hypotension (systolic blood pressure below 80 mmHg) 2. Complete AV block treated with unipolar pacemaker therapy 3. Currently implanted vagus nerve stimulation (VNS) device, baroreceptor activation therapy (BAT) device, other nerve stimulator, artificial or donor heart, or ventricular assist device (VAD) 4. Heart failure of non-ischemic origin for less than 6 months, or due to congenital heart disease, hypertrophic obstructive cardiomyopathy, or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) 5. Moderate (3+) or severe (4+) aortic valve or mitral valve stenosis; moderate (3+) or severe (4+) aortic valve insufficiency; or severe (4+) mitral valve insufficiency 6. Symptomatic uncontrolled bradycardia 7. On renal dialysis 8. Involvement in any concurrent clinical study with an investigational therapy
Heart Failure, Heart Failure, Congestive, Heart Failure, Systolic, Cardiomyopathy, Heart & Vascular
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Stroke Prevention in the Wisconsin Native American Population

This project will develop a "Stroke Awareness Team" including training of Oneida Health Service Coaches working in partnership with the UW team for a population-based health awareness program. This team will develop a series of Oneida Nation Healthy Living and Stroke Awareness Events (from now on health events) to provide education as to the severity of the problem as well as our standard therapies for lifestyle change and risk factor avoidance. This will include education of the healthy members of the tribe including the children to identify signs of stroke and TIA in their elders as well as to develop healthy lifestyles at the earliest of ages to influence the elders to modify their risks.
Robert Dempsey, MD
All
55 Years to 80 Years old
N/A
This study is also accepting healthy volunteers
NCT04382963
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Inclusion Criteria:

• Participants receiving health care through the Oneida Health Council Program
• Participants deemed to be at high risk for stroke by modified Framingham assessment of medical history, including cerebral cardiovascular symptomatology, hypertension, diabetes, smoking, BMI
• Willingness to participate in the study, including two-year follow-up
• Controls will be selected using the same criteria with the exception that upon screening, they are not deemed to be at high risk for stroke.
Exclusion Criteria:

• Presence of established dementia
• Inability to participate in physical and exercise programs due to preexisting disability
• Illiteracy
• Prior carotid procedure altering ultrasound finding
• Presence of medical condition precluding participation or follow-up over a two-year period of time.
Cerebral infarction, Brain & Neurological, Prevention & Screening, Stroke, Atherosclerosis
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Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)

The effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and tolerability in HFpEF patients with a WHF event (HFpEF decompensation) who have been stabilized and initiated at the time of or within 30 days post-decompensation.
Ravi Dhingra
All
18 Years to 99 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03988634
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INCLUSION CRITERIA: 1. Signed informed consent must be obtained prior to participation in the study 2. Patients >=18 years of age, male or female 3. Current hospitalization for Worsening Heart Failure (WHF) (HFpEF decompensation), or within 30 days of discharge following a WHF event (defined as hospitalization, emergency department (ED) visit or out-of-hospital urgent HF visit, all requiring IV diuretics). Patients with a diagnosis of acute heart failure had to have symptoms and signs of fluid overload (i.e. jugular venous distention, edema or rales on auscultation or pulmonary congestion on chest x-ray). Eligible patients will be randomized after IV diuresis for HFpEF is given (and no earlier than 36 hours from their last ACEi dose if applicable) and within 30 days post-decompensation after presentation with acute HFpEF decompensation and meeting the following definitions of hemodynamic stability: Randomized patients will have been hemodynamically stable defined in this study as: 1. SBP >=100mmHg for the preceding 6 hours prior to randomization; no symptomatic hypotension 2. No increase (intensification) in IV diuretic dose within last 6 hours prior to randomization 3. No IV inotropic drugs for 24 hours prior to randomization 4. No IV vasodilators including nitrates within last 6 hours prior to randomization 4. HFpEF with most recent LVEF > 40% (within past 3 months) 5. Elevated NT-proBNP or BNP at the time of acute HFpEF decompensation or post-decompensation screening (and within 72 hours for out-of-hospital randomization, if applicable): a. Patients not in Atrial Fibrillation(AF) at the time of biomarker assessment: NT-proBNP >= 500pg/mL or BNP >= 150 pg/mL; patients in AF at the time of biomarker assessment: NT-proBNP >= 1000pg/mL or BNP >= 300 pg/mL b. Patients recruited in-hospital will be randomized based on the qualifying local lab value in-hospital NT-proBNP or BNP value. c. Patients enrolled post-decompensation can be randomized based on their NT-proBNP or BNP value in the following way: i. if enrolling in post-decompensation setting then need eligible screening/local NTproBNP/BNP within 72 hours of randomization. The test value could be from recent hospitalization if within 72 hours or ii. would require (re)drawing NT-proBNP or BNP labs in post-decompensation setting if the lab value is not already available within the last 72 hours). 6) Has not taken an ACEi for 36 hours prior to randomization EXCLUSION CRITERIA: 1. Any clinical event within the 90 days prior to randomization that could have reduced the LVEF (i.e., myocardial infarction (MI), coronary artery bypass graft (CABG), unless an echo measurement was performed after the event confirming the LVEF to be > 40% 2. Entresto™ (sacubitril/valsartan) usage within the past 60 days 3. eGFR < 20ml/min/1.73 m2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at most recent assessment prior to randomization and within 24 hours prior to inpatient randomization or 72 hours prior to outpatient randomization 4. Serum potassium > 5.2 mEq/L at most recent assessment prior to randomization and within 24 hours prior to inpatient randomization or 72 hours prior to outpatient randomization 5. Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major CV surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, within 30 days prior to randomization 6. Probable alternative diagnoses that in the opinion of the investigator could account for the patient's HF symptoms (i.e. dyspnea, fatigue) such as significant pulmonary disease (including primary pulmonary HTN), anemia or obesity. 7. Isolated right HF in the absence of left-sided structural heart disease 8. History of hypersensitivity (i.e. including angioedema), known or suspected contraindications, or intolerance to any of the study drugs including ARNIs (i.e. sacubitril/valsartan), and/or ARBs 9. Patients with a known history of angioedema due to any etiology 10. Patients with a history of heart transplant or LVAD, currently on the transplant list, or with planned intent to implant LVAD or CRT device within the initial three months of enrollment during the trial 11. A cardiac or non-cardiac medical condition other than HF with an estimated life expectancy of < 6 months 12. Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including suspected or confirmed amyloid heart disease (amyloidosis) 13. Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate > 110 bpm 14. Clinically significant congenital heart disease felt to be the cause of the patient's symptoms and signs of HF 15. Coronary or carotid artery disease or valvular heart disease likely to require surgical or percutaneous intervention within the duration of the trial 16. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study 17. Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as varices 18. Participation in any other clinical trial involving investigational agents or devices within the past 30 days 19. Current confirmed COVID19 infection 20. Past COVID19 infection with persistent symptom burden suspected due to COVID19 (further defined in Section 5.2). 21. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 22. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of investigational drug and for 7 days off of study drug. Highly effective contraception methods are defined in protocol.
Heart Failure With Preserved Ejection Fraction (HFpEF), Heart failure, Diastolic (congestive) heart failure, Heart failure, unspecified, Heart & Vascular
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PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban

Currently, warfarin is the only approved anticoagulation for patients with mechanical valves. The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban. Both the On-X aortic valve and apixaban have been approved for use by the US Food and Drug Administration (FDA) but they have not been approved to be used together.
Andreas De Biasi
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04142658
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Inclusion Criteria:

• Male or female at least 18 years of age at the time of giving informed consent.
• Participants currently receiving warfarin anticoagulation and who are able to receive warfarin with a target INR 2.0 to 3.0.
• Participants are able to take low-dose aspirin at a dose of 75 -100 mg daily or have a documented contraindication to aspirin use.
• Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.
• Female participants of childbearing potential, including those who are less than 2 years post-menopausal, must agree to, and comply with using a highly effective method of birth control (eg, barrier contraceptives [condom or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices or sexual abstinence) while partaking in this study. In addition, all women of childbearing potential must agree to continue to use birth control throughout the study until last study visit.
• Informed of the full nature and purpose of the study, including possible risks and side effects, given ample time and opportunity to read and understand this information, and sign and date the written informed consent before inclusion in the study.
Exclusion Criteria:

• Mechanical valve in any position other than aortic valve.
• Any cardiac surgery in the three months (90 days) prior to enrollment.
• Need to be on aspirin >100 mg daily or a P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel, or ticlopidine).
• Known hypersensitivity or other contraindication to apixaban.
• On dialysis or a creatinine clearance < 25 mL/min.
• Ischemic stroke or intracranial hemorrhage within 3 months.
• Active pathological bleeding at the time of screening for enrollment.
• Active endocarditis at the time of screening for enrollment.
• Pregnant, plan to become pregnant, or are breast feeding.
• On concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.
• History of non-compliance with recommended monthly INR testing.
Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Failure, Arterial embolism and thrombosis, Heart & Vascular
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Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging

The purpose of this research is assess imaging and identification of soft plaque that undergoes large deformations or strain will identify plaque vulnerable to rupture which could lead to 'silent strokes'. Validation of current study results with MRI will foster use of real-time ultrasound (US) strain imaging and strain indices as a screening tool for identifying normal human participants susceptible to increased vascular aging and developing plaque prone to rupture or micro-embolization. Current research will evaluate Lagrangian carotid strain imaging (LCSI) for prediction of vascular health on volunteers. In this study, investigators will evaluate age-related strain variations (due to plaque deposition) in the carotid artery, establishing groundwork that will help identify typical and atypical values for these indices. Investigator's hypothesis is that plaques with higher strain indices (softer plaques) are more prone to rupture than plaques with lower strain indices (stiffer) plaques, thus requiring intervention. Clinical criteria for treatment has focused primarily on the degree of stenosis. Long-term objectives are to provide non-invasive methods for screening participants at risk for vascular aging or plaque rupture in asymptomatic participants, expanding upon current criteria for risk assessments based on focal transient ischemic attack (TIA) or strokes. Variations in vessel strain have been associated with, or are precursors to, plaque deposition, vascular aging, or cerebrovascular diseases. Increased arterial strain and pressure changes have been linked to brain aging using magnetic resonance imaging (MRI) based vascular indices, and memory deficits commonly linked to Alzheimer dementia. Stiffening and thickening of the arterial walls have also been associated with cerebrovascular disease. Investigators hypothesize that strain indices as vascular biomarkers can be utilized for screening possible 'vulnerable participants' validated with MRI, with the potential ability to improve endothelial function and reverse vascular aging. Strain indices may enable differentiating study participants with vascular cognitive impairment (VCI) from other dementias. Cognitive testing is unable to make this differentiation.
Tomy Varghese, PhD
All
18 Years and over
This study is also accepting healthy volunteers
NCT04632485
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Inclusion Criteria:
Aim 1 (Ultrasound (US) only):
• Adults at least 18 years
• Are able to provide written informed consent on their own behalf Aim 2 (US and MRI):
• Participation in the US study (Aim 1)
• Determined by presence of hypoechogenic or echolucent lipid-rich soft plaque during initial ultrasound imaging session
• Adults willing to participate over 5 years
Exclusion Criteria:
Aim 1 (US only)
• Women that are currently pregnant
• Inability to cooperate with the ultrasound study, in particular those unable to sit without gross movement for the duration the ultrasound study (estimated at 60-90 minutes)
• Open wounds or sores in the anterior neck
• History of cardiac disease, stroke or TIA
• History of statin medication
• History of hypertension medications Aim 2 (US and MRI):
• Women that are currently pregnant
• Inability to cooperate with the ultrasound study, in particular those unable to sit without gross movement for the duration the ultrasound study (estimated at 60-90 minutes)
• Patients that require sedative medication for imaging
• Contraindications to MR
• Unable to lie in the MRI scanner for 45-60 minutes
• Patients with a contraindication to gadolinium based contrast agents, including allergy or impaired renal function (per University of Wisconsin Health Guidelines)
Healthy, Carotid Artery Diseases, Healthy Volunteers
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First in Human Trial of Topical VT30 in Pts With Venous/Lymphatic Malformations Assoc With PIK3CA or TEK Gene Mutations

VT30-101 is a 2-part first-in-human trial of topically administered VT30 to subjects with cutaneous venous malformations, lymphatic malformations, or mixed venolymphatic malformations associated with PIK3CA or TEK mutations. Part 1 is a 4-week treatment, open-label, 4-sequence, escalating repeat-application cohort study, with intra-subject and inter-cohort dose escalation. Part 2 is a 12-week treatment, randomized, placebo-controlled, double-blind, safety and exploratory efficacy study. Part 2 will be initiated only after the successful completion of Part 1 with results that demonstrate the general safety and tolerability of topically applied VT30. Up to 12 subjects who complete Part 1 may be enrolled into Part 2 of the study. The primary objective is to evaluate the safety and tolerability of VT30. The study will also determine the dose and regimen of VT30 to be carried into Part 2 of the protocol. Other aims include documenting plasma drug levels of VT30 and VT10 and, on an exploratory basis, examining pharmacologic target engagement and change in potential efficacy readouts.
Beth Drolet, MD
All
18 Years to 60 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04409145
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Inclusion Criteria:
1. Have signed the current approved informed consent form 2. Have a clinically or phenotypically defined VM, LM, or mixed VLM affecting the skin 3. Lesion genotyping confirms either PIK3CA or TEK mutations, known to be pathogenic 4. Agrees to use contraception if of childbearing potential 5. Be willing and able to comply with the protocol and be available for the entire study 6. Be at least 18 to 60 years of age 7. Lesion must be amenable to defining a contiguous study treatment area of 140 cm2
Exclusion Criteria:
1. Lesion to be treated is on the face or involves mucosa 2. Presence of ulcerations on the target-treatment lesion 3. Known systemic hypersensitivity to the VT30 drug substance, its inactive ingredients, or the vehicle 4. Uncontrolled diabetes mellitus 5. Hyperlipidemia that is poorly controlled on current treatment 6. Pregnant or nursing, planning to become pregnant, or planning to father a child during the study 7. History of malignancy except successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix 8. Major surgery within 8 weeks of Screening, or a surgical, laser or other procedure involving the target lesion within 8 weeks of Screening, or planned to occur during the study 9. Any other medical or personal condition that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the subject, or may preclude the subject's successful completion of the clinical study 10. Medically significant infection (eg, cellulitis or abscess, or a systemic infection) within 8 weeks of Screening 11. Ongoing therapy with another topical treatment or any medication that inhibits PI3K, Akt pathway, or the mTOR pathway, or in the opinion of the Investigator, the subject requires systemic therapy for their vascular malformation condition 12. Use of a biologic or systemic immunosuppressive agent within 3 months of Screening 13. Systemic use of corticosteroids, within 30 days of Screening 14. Treatment with a small molecule investigational product within 30 days of Screening, or with any investigational biologic products within 3 months of Screening 15. Positive for hepatitis C antibody, hepatitis B surface antigen, hepatitis B core antibody, or human immunodeficiency virus 16. Alanine transaminase or aspartate transaminase laboratory values in excess of 1.5X the upper limit of normal at Screening 17. Hemoglobin A1c is >8% 18. Any other clinically significant laboratory or testing abnormality that, in the opinion of the Investigator, might confound the study, interfere with the subject's ability to complete the study, or represent a meaningful safety risk upon study enrollment
Venous Malformation, Lymphatic Malformation, Venolymphatic Malformation, Lymphangioma, any site
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Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction (GOLDILOX)

A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.
Amish Raval, MD
All
21 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04610892
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Inclusion Criteria:
1. Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomization within 42 days after signing the full ICF, and must adhere to the schedules of activities. 2. Women must be ≥ 40 years of age at the time of signing the ICF. Men must be ≥ 21 years of age at the time of signing the ICF. 3. Participant must: 1. be 30 to 365 days after presumed type-1 (ie, due to plaque rupture or erosion) MI (either STEMI or NSTEMI) at the time of enrollment. 2. have persistent inflammation, defined as hs CRP ≥ 1 mg/L, as measured centrally at screening Visit 1. 4. Participant must have body mass index within the range 18 to 40 kg/m2 inclusive. 5. For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at screening Visit 1 by one of the following: 1. Postmenopausal, defined as amenorrhea for ≥ 12 months following cessation of all exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range. 2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization. 6. Participant must have an evaluable, pre-randomization CTA with quantifiable, non calcified plaque.
Exclusion Criteria:
1. History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study. 2. Percutaneous coronary intervention or diagnostic angiogram planned after screening. Eligible participants who have a diagnostic angiogram performed in the absence of undergoing a new PCI may continue screening after the diagnostic angiogram has been performed or may be rescreened. 3. History of or planned coronary artery bypass grafting. 4. Documented episode of post-MI pericarditis in the 3 months before enrollment. 5. Ongoing New York Heart Association Class IV HF. 6. Increased risk of bleeding 1. Patients with history or presence of any bleeding disorder. 2. Signs of ongoing bleeding at screening (eg, identified macroscopic bleeding, low hemoglobin presumed to be caused by bleeding) or high risk for major bleeding in accordance with the Investigator's assessment. 3. Need for chronic therapeutic anticoagulation therapy anticipated to be required throughout the course of the study (short-term treatment with prophylactic doses of heparin/low molecular weight heparin are allowed). 4. Known severe liver disease. 7. History or presence of any of the following: 1. Ongoing infection or febrile illness that in the opinion of the investigator may be the cause of elevated hs-CRP on screening. 2. Ongoing atrial fibrillation or flutter. 3. Cancer within 5 years before randomization, with the exception of non melanoma skin cancer. 4. Alcohol or substance abuse within 6 months before randomization, as judged by the investigator. 5. Known history of hypersensitivity reactions to other biologics, to human IgG preparations, or to any component of MEDI6570, or ongoing severe allergy as judged by the investigator. 6. Patients with active positive results on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV. 8. Any clinically important abnormalities in clinical chemistry, hematology, coagulation parameters, as judged by the investigator. 9. BP values at screening: 1. Systolic BP < 90 mmHg or > 180 mmHg. 2. Diastolic BP > 100 mmHg. 3. Participants who are excluded based on elevated BP may be rescreened following adequate treatment. 10. Participants with any of the following contraindications to CTA: 1. eGFR < 50 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration equation, or end stage renal disease treated with kidney transplant or renal replacement therapy. 2. Allergy to iodinated contrast. 3. History of contrast-induced nephropathy. 4. Contraindication to nitroglycerin. 5. Rapid heart rate that is uncontrolled by medical therapy. 6. Inability to hold breath for at least 6 seconds. 11. Receipt of any investigational device or therapy within 6 months or 5 half lives before screening (whichever is longer). This criterion does NOT apply for inactive, non replicating COVID-19 vaccines approved by Health Authorities or under emergency use authorization. 12. Planned participation in an additional investigational study of an intervention or biologic before the end of the follow-up period. Participation in observational studies or studies without investigational drugs or devices is allowed. 13. Participants who are legally institutionalized. 14. An employee or close relative of an employee of the sponsor, the CRO, or the study site, regardless of the employee or close relative's role.
Coronary Heart Disease (CHD), ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction, Atherosclerotic heart disease of native coronary artery, Heart & Vascular
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Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System (COMPETENCE)

This is a prospective, multi-center, unblinded, randomized, controlled, and non-inferiority study comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3 LVAS).
Ravi Dhingra
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT01187368
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Inclusion Criteria:
The following is a list of general inclusion criteria:
• Age ≥ 18 years
• Left Ventricular Ejection Fraction (LVEF) < 30%
• NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure
• Inotrope dependent OR Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes
• Patient is able to provide written informed consent
• More detailed inclusion criteria information is noted in the study protocol
Exclusion Criteria:
1. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy 2. Technical obstacles which pose an inordinately high surgical risk 3. Existence of ongoing mechanical circulatory support (MCS) other than IABP and Impella 5.0 or 5.5 4. Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) and elevated LDH equal or greater than 600 IU/L. 5. Positive pregnancy test if of childbearing potential 6. Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis 7. History of any organ transplant 8. Platelet count <100,000/mL 9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues 10. History of confirmed, untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter within 6 months of enrollment 11. Presence of an active, uncontrolled infection 12. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy that the investigator will require based upon the patient's health status 13. Presence of remarkable pre-defined end-organ dysfunction. 14. Patient has moderate to severe aortic insufficiency without plans for correction during pump implant 15. Low albumin
•removed from recent exclusion criteria 16. Planned Bi-VAD support prior to enrollment 17. Patient has known hypo- or hyper coagulable state such as disseminated intravascular coagulation and heparin induced thrombocytopenia (HIT) 18. Participation in any other clinical investigation that is likely to confound study results or affect the study 19. Any condition other than heart failure that could limit survival to less than 24 months 20. Patients refusing blood transfusion
Heart Failure, Cardiomyopathy, Heart & Vascular
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Pecto-Intercostal Fascial Plane Block Study

This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). 100 participants will be recruited and can expect to be on study for 100 days.
Pat Meyer
All
18 Years to 80 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT04928339
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Inclusion Criteria:

• Participant provides consent to participate in study
• Ideal body weight (IBW) is >50kg
• Participant is planned to undergo coronary artery bypass graft or single valve repair/replacement surgery via median sternotomy
• Participant is undergoing an elective procedure
Exclusion Criteria:

• Participant is unable or unwilling to give consent
• Non-English speaking
• Known or believed to be pregnant or is currently breastfeeding
• Participant is a prisoner
• Clinically unstable per discretion of the Investigator
• Participant requires urgent/emergent surgery
• History of previous sternotomy
• Preoperative coagulopathy (INR >1.4, platelets <100,000) or ongoing anticoagulation or anti-platelet therapy (except aspirin 81mg)
• Allergy or sensitivity to amide-type local anesthetics, dexmedetomidine or ketamine
• Participant has decompensated heart failure
• Severe left ventricle dysfunction (defined quantitatively as an ejection fraction of less than or equal to 35%) or right ventricle dysfunction (defined qualitatively as "severe")
• Diagnosis of cirrhosis or end-stage liver disease
• Requires the use of mechanical circulatory support pre-operatively
• Participant uses chronic opioids (meaning at the time of the preoperative screening evaluation by the study team, the patient is prescribed and taking any opioid pain medication)
Cardiac Surgery, Opioid Use, Unspecified
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The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope

Syncope is defined as transient loss of consciousness associated with inability to maintain postural tone with rapid and spontaneous recovery. The purpose of this study is to assess the effects of sublingual administration of a new medication called CPC on tilt-induced syncope in patients with a history of vasovagal syncope (VVS). 132 participants will be enrolled at the University of Wisconsin - Madison. Each participant will be in the study for 1 day.
Mohamed Hamdan, MD
All
18 Years to 50 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04972123
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Inclusion Criteria:
1. Established diagnosis of typical vasovagal syncope 2. Age 18-50 years
Exclusion Criteria:
1. Systolic BP >130 mmHg 2. History of hypertension or cardiac arrhythmias 3. History of cardiovascular disease or cerebral ischemic events 4. Allergic reaction to any of the drug components 5. Contraindication to tilt testing 6. Any physical or psychological symptom, based on the clinical judgment of the investigators that would make a participant unsuitable for the study 7. Any use of a medication(s) based on the clinical judgment of the investigators that would make a participant unsuitable for the study (e.g. fludrocortisone, theophylline, prazosin, doxazosin, terazosin, MAO-inhibitors, pseudoephedrine, decongestant and PDE5 inhibitors). 8. Unwilling to discontinue Midodrine or beta-blocker therapy 48 hours before tilt table testing. 9. Women who are pregnant (confirmed with pregnancy test on day of study) or lactating.
Syncope, Vasovagal, Syncope and collapse, Heart & Vascular
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Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)

Prospective, non-randomized, , multicenter study with two independent arms: - Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. - Up to 40 additional subjects may be implanted in Continued Access Phase under t the Primary Study Arm only - Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis. Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 40 additional subjects implanted in Continued Access (Primary Study arm)
Dai Yamanouchi, MD
All
19 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03728985
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Inclusion Criteria:
1. Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following:
• Fusiform aneurysm diameter ≥ 5 cm
• Saccular aneurysm (no diameter requirement)
• Rapid aneurysm growth (≥ 5 mm in one year) 2. Aortic aneurysm that involves the abdominal aorta, with:
• Involvement of at least one visceral vessel and aneurysmal extension as far as 65 mm proximal to the celiac artery, and/or
• No normal aorta between the upper extent of aneurysm and renal artery(s) 3. Adequate access for TAMBE Device components (femoral, axillary, and / or brachial arteries as required) 4. Age ≥ 19 years at the time of informed consent signature 5. Male or infertile female 6. Patient assessment favors an endovascular approach when compared to open surgical repair, as deemed by the treating physician 7. Capable of complying with protocol requirements, including follow-up 8. An Informed Consent Form signed by Subject or legal representative 9. Sufficient distal landing zones in both iliac arteries, with at least one patent internal iliac artery and without planned placement of a branched iliac device, or planned coverage/occlusion/embolization of any patent internal iliac artery. 10. Appropriate aortic anatomy to receive the TAMBE Device defined as all of the following:
• For the TAMBE aortic component, proximal aortic landing zone diameters between 22-34 mm
• Proximal seal zone ≥ 20 mm in length
• Aortic neck angle ≤ 60°
• Distal landing zone (iliac arteries) 8-25 mm
• Distal seal zone in iliac arteries of at least 10 mm in length
• Renal artery landing zone diameters between 4-10 mm
• Celiac and superior mesenteric artery landing zone diameters between 5-12 mm
• ≥ 15 mm landing zone in each branch vessel
• Landing zones in the proximal and distal aorta and all branch vessels cannot be aneurysmal, heavily calcified, or heavily thrombosed
• Patent left subclavian artery Secondary Study Arm Only: 11. If aneurysm extends greater than 65 mm above celiac artery, proximal extension with a CTAG Device is required. The aortic landing zone diameter treatment range with the CTAG Device is 19.5-32 mm 12. The most proximal aspect of the aneurysm is at least 2.0 cm distal to the left subclavian artery. 13. The most proximal aortic device seal zone will be within native aorta or a previously-deployed TAG or CTAG Device • Placement inside a Dacron graft or another device manufacturer's stent graft will not be supported
Exclusion Criteria:
The patient is / has: 1. Prior open, aortic surgery of the ascending aorta or aortic arch 2. Ruptured or leaking aortic aneurysm 3. Aneurysmal dilatation due to chronic aortic dissection 4. Infected aorta 5. Mycotic aneurysm 6. Life expectancy <2 years 7. Myocardial infarction or stroke within 1 year of treatment (staged or index procedure) 8. Systemic infection which may increase risk of endovascular graft infection 9. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome 10. Participation in an investigational drug study (within 30 days of last administration) or investigational medical device study (within 1 year of implant) from the time of study screening 11. History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment 12. Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access 13. A branch vessel(s) that is dissected or has significant calcification, tortuosity, thrombus formation that would interfere with device delivery or ability to exclude from blood flow 14. Known sensitivities or allergies to the device materials 15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin 16. Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta 17. Renal Insufficiency (creatinine value > 1.8 mg/dL, GFR < 30, or patient undergoing dialysis) 18. Known concomitant aneurysm of the ascending aorta or aortic arch anticipated to require surgical intervention within one year of study treatment
Thoracoabdominal Aortic Aneurysm, Thoracoabdominal aortic aneurysm, without rupture, Heart & Vascular
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CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM receiving available standard of care (SoC). For more information, please visit https://www.cardio-ttransform.com.
Farhan Raza
All
18 Years to 90 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04136171
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Inclusion Criteria:

• Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal or abstinent. If engaged in sexual relations of child-bearing potential, agree to use 1 highly effective contraceptive method
• Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the participant or the participant's non-pregnant female partner must be using a highly effective contraceptive method
• Amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or equivalent) staining OR technetium scintigraphy (99mTc -3,3-diphosphono-1,2- propanodicarboxylic acid [DPD-Tc], 99m Tc-pyrophosphate [PYP-Tc], or 99m Tc-hydroxymethylene-diphosphonate [HMDP-Tc]) with Grade 2 or 3 cardiac uptake in the absence of abnormal light chains ratio, centrally confirmed
• End-diastolic interventricular septum thickness of > 12 millimeters (mm) on Screening echocardiogram
• New York Heart Association (NYHA) class I-III
Exclusion Criteria:

• Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening
• Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease
• Monoclonal gammopathy of undetermined significance (MGUS) and/or alterations in immunoglobulin free light chain (FLC) ratio unless fat, bone marrow, or heart biopsy confirming the absence of light chain and the presence of TTR protein by mass spectrometry or immunoelectron microscopy. For participants with chronic kidney disease (CKD) and without presence of monoclonal protein in blood and urine, the acceptable FLC ratio is 0.26-2.25. Results different from that may be discussed with local hematologist, Investigator and Medical Monitor if the risks associated with the biopsy outweigh the benefits
• Prior liver or heart transplant, and/or Left Ventricular Assist Device (LVAD) or anticipated liver transplant or LVAD within 1 year after randomization
• Current or previous treatment with Tegsedi™ (inotersen) or Onpattro™ (patisiran) or other oligonucleotide or ribonucleic acid (RNA) therapeutic (including small interfering ribonucleic acid [siRNA]; does not apply to COVID-19 mitochondrial [mRNA] vaccinations)
• Current treatment with diflunisal, doxycycline, with or without ursodeoxycholic acid, and/or non-dihydropyridine calcium-channel blocker (e.g., verapamil, diltiazem). Participants receiving any of these agents must respect a wash-out period of 14 days before randomization.
Heart & Vascular, Infections, Immune System & Allergies, Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
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CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial (CardiAMP CMI)

Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment Treatment Group: Subjects treated with aBMC using the CardiAMP cell therapy system Sham Control Group: Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)
Amish Raval, MD
All
21 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03455725
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Inclusion Criteria:
1. Male or female 21 to 80 years of age 2. Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina. 3. Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs. 4. Evidence of inducible myocardial ischemia on baseline stress testing 5. Obstructive coronary disease unsuitable for conventional revascularization 6. Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period). 7. Able to complete an exercise tolerance test on the treadmill 8. Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography. 9. Qualification of a pre-procedure screening of bone-marrow aspiration Exclusion Criteria Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
Chronic ischemic heart disease, Heart & Vascular, Refractory Angina, Chronic Myocardial Ischemia
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Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism (HI-PEITHO)

There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.
Kurt Jacobson, MD, MHSA
All
18 Years to 80 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT04790370
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Inclusion Criteria:

• Age 18-80 years, inclusive
• Objectively confirmed acute PE, based on computed tomography pulmonary angiography (CTPA) showing a filling defect in at least one main or proximal lobar pulmonary artery
• Elevated risk of early death/hemodynamic collapse, indicated by at least two of the following new-onset clinical criteria: 1. ECG-documented tachycardia with heart rate ≥100 beats per minute, not due to hypovolemia, arrhythmia, or sepsis; 2. SBP ≤ 110 mm Hg for at least 15 minutes; 3. respiratory rate > 20 x min-1 or oxygen saturation on pulse oximetry (SpO2) < 90% (or partial arterial oxygen pressure < 60 mmHg) at rest while breathing room air;
• Right-to-left ventricular (RV/LV) diameter ratio ≥ 1.0 on CTPA
• Serum troponin I or T levels above the upper limit of normal
• Signed informed consent
Exclusion Criteria:

• Hemodynamic instability*, i.e. at least one of the following present: 1. cardiac arrest or need for cardiopulmonary resuscitation; 2. need for ECMO, or ECMO initiated before randomization 3. PE-related shock, defined as: (i) SBP < 90 mmHg, or vasopressors required to achieve SBP ≥ 90 mmHg, despite an adequate volume status; and (ii) end-organ hypoperfusion (altered mental status; oliguria/anuria; increased serum lactate); 4. isolated persistent hypotension (SBP < 90 mmHg, or a systolic pressure drop by at least 40 mmHg for at least 15 minutes), not caused by new-onset arrhythmia, hypovolemia, or sepsis * Patients who presented with temporary need for fluid resuscitation and/or low-dose catecholamines may be included, provided that they could be stabilized within 2 hours of admission and maintain SBP of ≥ 90 mmHg and adequate organ perfusion without catecholamine infusion.
• Need for admission to an intensive care unit for a reason other than the index PE episode. NB: Patients who test positive for SARS-CoV-2 can be enrolled where the investigator believes that the pulmonary embolism is the dominant pathology in the patient's clinical presentation and qualifying cardiorespiratory parameters.
• Temperature above 39 degrees C / 102.2 degrees F
• Logistical reasons limiting the rapid availability of interventional procedures to treat acute PE (e.g., during the outbreak of an epidemic)
• Index PE symptom duration > 14 days
• Active bleeding
• History of intracranial or intraocular bleeding at any time
• Stroke or transient ischemic attack within the past 6 months, or previous stroke at any time if associated with permanent disability
• Central nervous system neoplasm, or metastatic cancer
• Major neurologic, ophthalmologic, abdominal, cardiac, thoracic, vascular or orthopedic surgery or trauma (including syncope-associated with head strike or skeletal fracture) within the past 3 weeks
• Platelet count < 100 x 109 x L-1
• Patients who have received a once-daily therapeutic dose of LMWH or a therapeutic dose of fondaparinux within 24 hours prior to randomization
• Patients who have received one of the direct oral anticoagulants apixaban or rivaroxaban within 12 hours prior to randomization
• Patients who have received one of the direct oral anticoagulants dabigatran or edoxaban for the index PE episode, as these drugs are not approved for patients who have not received heparin for at least 5 days
• Administration of a thrombolytic agent or a glycoprotein IIb/IIIa receptor antagonist during the current hospital stay and/or within 30 days, for any reason
• Chronic treatment with antiplatelet agents other than low-dose acetylsalicylic acid or clopidogrel 75 mg once daily (but not both). Dual antiplatelet therapy is excluded.
• Chronic treatment with a direct oral anticoagulant (apixaban, dabigatran, edoxaban or rivaroxaban)
• Chronic treatment with a vitamin K antagonist, or known coagulopathy including severe hepatic dysfunction, with an International Normalized Ratio (INR) > 1.5
• Pregnancy or lactation
• Previous inclusion in the study
• Known hypersensitivity to alteplase, LMWH or UFH, or to any of the excipients
• Life expectancy less than 6 months
Pulmonary Embolism, Pulmonary embolism, Heart & Vascular
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Meal Timing and Blood Pressure

Brain blood flow, blood pressure, and neurovascular control mechanisms will be measured in middle-aged adults before and after a brief intervention period. The intervention will consist of changing the time in which the participant consumes food each day.
JILL BARNES
All
50 Years to 65 Years old
N/A
This study is also accepting healthy volunteers
NCT04133701
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Inclusion Criteria:

• BMI ≤ 34 kg/m2
• Non-smoking
• Sedentary or recreationally active
• ≤ 2 Alcoholic drinks per day
• Female subjects: Perimenopausal/Postmenopausal
Exclusion Criteria:

• History or evidence of hepatic, renal, hematological, peripheral vascular disease, or stroke/neurovascular disease, diabetes, uncontrolled hypertension, sleep apnea
• On medications used to treat/manage diseases listed above
• Work overnight shifts
• Clinically diagnosed anxiety or depression
• Pregnant or trying to become pregnant
• Significant surgical history
• Other significant medical conditions at investigator's discretion
Blood Pressure, Neurovascular Control, Healthy Volunteers
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PROACTIVE-HF IDE Trial Heart Failure NYHA Class III (PROACTIVE-HF)

This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).
Farhan Raza
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04089059
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Inclusion Criteria 1. Subject has given written informed consent 2. Male or female, at least 18 years of age 3. Diagnosis and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of Screening 4. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented. 5. HF related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit for IV diuretics within 12 month (last hospitalization should be 30 days before Screening /Enrollment) and/or N-terminal pro B-type Natriuretic Peptide (NT proBNP) at time of Screening/ Enrollment defined as: 1. Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL. 2. Subjects with LVEF > 50%: NT-proBNP ≥ 800 pg/mL . Thresholds for NT-proBNP (for both LVEF ≤ 50% and LVEF > 50%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2 6. Subjects should be on diuretic therapy 7. Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 1.3lb) against the ventral thoracic surface for up to 2 minutes per day while in a seated position, as well as dock and undock the myCordella™ Patient Reader 8. Subjects with sufficient eyesight, hearing, and mental capacity to respond to the myCordella™ Patient Reader's audio/visual cues and operate the myCordella™ Patient Reader 9. Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home 10. Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up Exclusion Criteria 1. Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNI), and beta-blockers) due to hypotension or renal dysfunction 2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes) 3. Subjects with history of recurrent pulmonary embolism ( ≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis (< 3 month prior to Screening Visit) 4. Subjects who have had a major cardiovascular (CV) event (e.g.myocardial infarction, stroke) within 3 months of the Screening Visit 5. Unrepaired severe valvular disease 6. Subjects with congenital heart disease or mechanical/tissue right heart valve(s) 7. Subjects with known coagulation disorders 8. Subjects with a hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take dual antiplatelet or anticoagulants for one month post implant 9. Known history of life threatening allergy to contrast dye 10. Subjects whereby RHC is contraindicated 11. Subjects with an active infection at the Cordella PA Sensor Implant Visit 12. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis 13. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit 14. Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or lung or heart transplant) in the next 12 months 15. Subjects who are pregnant or breastfeeding 16. Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance 17. Severe illness, other than heart disease, which would limit survival to <1 year 18. Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study 19. Subjects enrolled in another investigational trial with an active treatment arm 20. Subject who is in custody by order of an authority or a court of law
Heart & Vascular, Aging & Geriatrics, Heart Failure NYHA Class III
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Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study (ARB-PMCF)

ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.
Satoru Osaki
All
18 Years and over
NA
This study is NOT accepting healthy volunteers
NCT04761120
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Inclusion Criteria:
1. Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following: 1. implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cut zone removal for MR repair 2. implant of a full Tailor Ring without cut zone removal for TR repair, or 3. implant of a Tailor Band or partial Tailor Ring with cut zone removed for primary TR repair. 2. Subject's cardiac surgery will be performed by a study investigator. 3. Subject will be ≥18 years old at the time of their annuloplasty implant(s). 4. Subject provides written informed consent and agrees to comply with all required study visits and procedures.
Exclusion Criteria:
1. Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent. 2. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent. 3. Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s). 4. Subject cannot be unambiguously assigned to a treatment group due to missing data on repair indication(s) or the model and configuration (cut zone removed or not) of their Abbott annuloplasty implant(s). 5. Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care. 6. Subject has anomalous anatomy or medical, surgical, psychiatric or social history or conditions that, in the investigator's opinion, would limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements
Multiple valve diseases, Nonrheumatic mitral valve disorders, Nonrheumatic mitral valve insufficiency, Nonrheumatic mitral valve disorder, unspecified, Nonrheumatic tricuspid valve disorders, Heart & Vascular, Mitral Regurgitation, Tricuspid Regurgitation, Valvular Heart Disease
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COVID Protection After Transplant-Immunosuppression Reduction (CPAT-ISR)

This study will enroll individuals who have: - Completed, at a minimum, a full 2-dose course but no more than 4 of either the Moderna messenger RNA (mRNA) based coronavirus infectious disease 19 (COVID-19) vaccine or the Pfizer-BioNTech mRNA based COVID-19 vaccine, and - An antibody response ≤ 250 U/mL measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppression and a high prevalence of non-transplant risk factors such as obesity and diabetes.
Jacqueline Garonzik Wang
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05077254
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Inclusion Criteria:
Individuals who meet all the following criteria are eligible for enrollment as study participants- 1. Able to understand and provide informed consent 2. Recipient of a kidney or liver transplant ≥12 months prior to enrollment, without allograft rejection in the 6 months preceding enrollment 3. Negative for anti-donor human leukocyte antigens (HLA) antibodies at screening (Central Lab Test Determination). 4. Currently taking one of the following calcineurin inhibitors (CNI)-based immunosuppressive regimens:
• Tacrolimus plus Mycophenolate Mofetil (MMF) or Mycophenolic Acid (MPA), with or without a corticosteroid
• Tacrolimus with trough ≥ 5ng/mL with or without ≤5 mg of prednisone or equivalent 5. Received a minimum of 2 and no more than 4 doses of either the Moderna coronavirus infectious disease 19 (COVID-19) vaccine or Pfizer-BioNTech COVID-19 vaccine at least 30 days prior to study entry 6. Serum antibody negative or low (titer ≤ 250 U/mL) at ≥ 30 days from the last dose of mRNA COVID-19 vaccine, measured using the Roche Elecsys®) severe acute respiratory syndrome coronavirus type 2 serological (anti-SARS-CoV-2) S assay, and 7. Participant's transplant physician or midlevel practitioner who is clinically licensed to prescribe and manage immunosuppression must confirm the participant's eligibility based on medical history.
Exclusion Criteria:
Individuals who meet any of these criteria are not eligible for enrollment as study participants- 1. Currently on an immunosuppressive regimen different from the three regimens described in the Inclusion Criteria, for example (but not limited to) those including sirolimus, everolimus, belatacept, or azathioprine 2. Recipient of any allograft other than a kidney or liver 3. Participant is pregnant 4. Any past history of Donor Specific Antibody (DSA) using local site standards 5. Currently taking any systemic immunosuppressive agent, other than their prescribed transplant immunosuppression 6. Recipients of any COVID-19 vaccine other than the Moderna COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine 7. Known history of severe allergic reaction to any component of an authorized or licensed COVID-19 vaccine 8. Thrombotic events, myocarditis, or pericarditis temporally associated with a prior dose of COVID-19 vaccine 9. History of heparin-induced thrombocytopenia 10. Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months 11. More than minimal graft dysfunction, in accordance with study definition 12. Receipt of any cellular depleting agent (e.g. antithymocyte globulins (ATG), rituximab, alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment 13. Concurrent autoimmune disease at risk for exacerbation with immunosuppression reduction 14. Any untreated active infection including BK viremia >10^4 copies 15. Infection with human immunodeficiency virus (HIV) 16. Recent (within one year) or ongoing treatment for malignancy with the exception of:
• Non- melanomatous skin cancer definitively treated by local therapy, and
• Definitively treated carcinoma-in-situ of the cervix (Stage 0 cervical cancer) 17. Treatment or prophylaxis of COVID-19 with a monoclonal antibody product or convalescent plasma within 6 months preceding enrollment, or 18. Any past or current medical problems, treatments, or findings which, in the opinion of the investigator, may:
• pose additional risks from participation in the study,
• interfere with the candidate's ability to comply with study requirements, or
• impact the quality or interpretation of the data obtained from the study.
Other immunodeficiencies, Complications of transplanted organs and tissue, Transplant, Kidney Transplant Recipients, Liver Transplant Recipients
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Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia (ORION-16)

This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C).
Amy Peterson
All
12 Years to 17 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04652726
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Inclusion Criteria:

• Heterozygous Familial Hypercholesterolemia (HeFH) diagnosed either by genetic testing or on phenotypic criteria
• Fasting LDL-C >130 mg/dL (3.4 mmol/L) at screening
• Fasting triglycerides <400 mg/dL (4.5 mmol/L) at screening
• On maximally tolerated dose of statin (investigator's discretion) with or without other lipid-lowering therapy; stable for ≥ 30 days before screening
• Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m2 at screening
Exclusion Criteria:

• Homozygous familial hypercholesterolemia (HoFH)
• Active liver disease
• Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome
• Major adverse cardiovascular events within 3 months prior to randomization
• Previous treatment with monoclonal antibodies directed towards PCSK9 (within 90 days of screening)
• Recent and/or planned use of other investigational medicinal products or devices Other protocol-defined inclusion/exclusion criteria may apply
Familial Hypercholesterolemia - Heterozygous, Disorders of lipoprotein metabolism and other lipidemias, Children's & Adolescent Health, Heart & Vascular
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