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Suggestions within category "Heart & Vascular"


23 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
Fetal Arrhythmia, Supervision of high risk pregnancy, Healthy Volunteers
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E-Cigarette Effects on Markers of Cardiovascular and Pulmonary Disease

This study is designed to enhance the understanding of the possible health effects of e-cigarette use by relating the acute and long-term use of e-cigarettes and conventional cigarettes ("products") to well-validated cardiovascular and pulmonary disease biomarkers. Participants will be enrolled in 3 groups: exclusive e-cigarette users, exclusive cigarette smokers, and a control group of never-users. Participants can expect up to 4 weeks of study participation.
James Stein
All
18 Years and over
NA
This study is also accepting healthy volunteers
NCT03863509
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Inclusion Criteria:

• able to read and write English
• no plans to quit smoking and/or e-cig use in the next month
• not using cigars/smokeless/snus tobacco >/= 1 time per week
• having a stable pattern of current product use
• able to walk at least 2 blocks without assistance or stopping
• Specific to Exclusive Smokers:
• smokes daily
• >/= 5 cigs/day for last 6 months
• < 3 uses E-cigs in lifetime
• >/= 5 ppm carbon monoxide (CO)
• Cotinine > 100 ng/ml
• Specific to Exclusive E-cig users:
• >/= 5 days per week E-cig use for last 3 months
• Cotinine > 100 ng/ml
• Specific to Never-users
• < 100 cigarettes in a lifetime, none for > 5 years
• < 3 E-cig uses in a lifetime
• Continine < 100 ng/ml
Exclusion Criteria:

• current use of a smoking cessation medication
• women who are pregnant or plan to get pregnant in the coming month
• women who might be pregnant
• incarcerated individuals
• history of sarcoidosis in past 5 years, or active interstitial lung/pulmonary fibrosis
• history of positive COVID-19 test
Tobacco Use, E-Cigarette Use, Cardiovascular Diseases, Pulmonary Disease, Nicotine dependence, Secondary hypertension, Atherosclerosis, Tobacco use, Prevention & Screening, Heart & Vascular, Lung & Respiratory
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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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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
• Stage IV or V chronic kidney disease (estimated glomerular filtration rate [eGFR]<30 mL/min/1.73m2)
• 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
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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 and over
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.
Carotid Stenosis, Vascular Diseases [C14], Heart & Vascular
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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
Vascular Diseases [C14], Children's & Adolescent Health, Digestive Health & Liver Disease, Food & Nutrition, Aortic Aneurysm, Thoracic, Aorta, Lesion
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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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Surveillance HeartCare® Outcomes Registry (SHORE)

This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.
Ravi Dhingra
All
15 Years and over
NA
This study is NOT accepting healthy volunteers
NCT03695601
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Inclusion Criteria:
1. Patients who are 15 years of age or older at the time of blood draw. 2. Received a heart transplant (primary or repeat) 3. Patients who have HeartCare initiated within 3 months post-transplant
Exclusion Criteria:
1. Patients who are pregnant at the time of blood draw.
Heart Transplant Rejection, Heart transplant rejection, Heart & Vascular, Transplant
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CardiAMP™ 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%.
• Cell potency assay score of '3'.
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. 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:
• Class C or higher diabetes mellitus
• Chronic kidney disease
•including baseline proteinuria (>300mg/24-hr, p/c 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.
• 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 or nifedipine (e.g. know hypersensitivity); and (12) Current substance abuse or addiction (cocaine, methamphetamine) *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. Pacemaker therapy that utilizes unilateral ventricular pacing with a right ventricular lead for complete AV block 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. Involvement in any concurrent clinical study with an investigational therapy
Cardiomyopathy, Heart Failure, Heart Failure, Congestive, Heart Failure, Systolic, 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.
Stroke, Atherosclerosis, Cerebral infarction, Brain & Neurological, Prevention & Screening
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Changes in NT-proBNP and Outcomes, Safety, and Tolerability in HFpEF Patients With Acute Decompensated Heart Failure (ADHF) Who Have Been Stabilized During Hospitalization and Initiated In-hospital or Within 30 Days Post-discharge (PARAGLIDE-HF)

The purpose of this study is to assess the effect of sacubitril/valsartan (LCZ696) vs. valsartan on changes in NT-proBNP and outcomes, safety and tolerability in patients with HFpEF (left ventricular ejection fraction (LVEF) > 40%) who have been stabilized during hospitalization for acute decompensated heart failure and initiated in-hospital or within 30 days post discharge.
Ravi Dhingra
All
40 Years and over
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 ≥40 years of age, male or female 3. Currently hospitalized for or within 30 days following discharge of an acute decompensated HFpEF admission. 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 no earlier than 36 hours and within 30 days post-discharge after presentation with acute HFpEF decompensation and meeting the following definitions of hemodynamic stability: In-hospital 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 i.v. diuretic dose within last 6 hours prior to randomization 3. No i.v. inotropic drugs for 24 hours prior to randomization 4. No i.v. vasodilators including nitrates within last 6 hours prior to randomization Out-of-hospital randomization patients will have been hemodynamically stabilized defined in this study as: 1. SBP ≥100mmHg; no symptomatic hypotension 2. No increase (intensification and/or change to IV) in diuretic dose within last 24 hours prior to randomization 3. No i.v. inotropic drugs for 24 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 screening (and within 72 hours from inhospital screening to out-of-hospital randomization, if applicable) 1. Patients not in 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 2. Patients recruited in-hospital will be randomized based on the qualifying local lab value in-hospital NT-proBNP or BNP value. In-hospital is the preferred method of enrollment. 3. Patients enrolled out-of-hospital can be randomized based on their NT-proBNP or BNP value in the following way: if enrolling in out-of-hospital 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 would require (re)drawing NT-proBNP or BNP labs in out-of-hospital 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., MI, CABG), unless an echo measurement was performed after the event confirming the LVEF to be >40% 2. Currently taking Entresto™ (sacubitril/valsartan) or any prior use 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. Specifically, patients with the following are excluded: 1. Severe pulmonary disease including chronic obstructive pulmonary disease (COPD) (i.e. requiring home oxygen, oral steroid therapy) or 2. Hemoglobin (Hgb) < 9.5 g/dL males and < 9 g/dL females within 30 days prior to randomization or 3. Body mass index (BMI) > 50 kg/m2 at randomization 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 < 12 months 12. Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including 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 Persistent symptoms may include, but are not limited to, continued cough, breathing difficulty, muscle/joint aches, and gastrointestinal symptoms from the time of COVID19 infection onward. 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 childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment. Basic contraception methods include: Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example, hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS).
Heart failure, Diastolic (congestive) heart failure, Heart failure, unspecified, Heart & Vascular, Heart Failure With Preserved Ejection Fraction (HFpEF)
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The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea

The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).
Mihaela Teodorescu, MD
All
21 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03745898
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Inclusion Criteria:

• Aged ≥ 21 years at the date of consent.
• History of chronic, stable heart failure with reduced ejection fraction with left ventricular ejection fraction (LVEF) ≤ 50% determined by echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, within the year prior to enrollment.
• Central sleep apnea, defined using as an apnea-hypopnea index (AHI) > 15/h with ≥ 50% central events (apnea and hypopneas).
• New York Heart Association (NYHA) Class III or IV, or NYHA Class II with any of the following: 1. at least one hospitalization for heart failure within the 24 months prior to enrollment or; 2. a BMI corrected BNP ≥ 300 pg/ml or a corrected NT-proBNP ≥ 1500 pg/ml or; 3. an ED visit for HF exacerbation where the patient has received an IV diuretic within 12 months of enrollment.
• Treatment with stable, optimized guideline-directed medical therapies (GDMT) according to applicable guidelines in the U.S. and Canada, where stable is defined as the addition of no new class of disease-modifying drug for ≥ 30 days prior to randomization (reasons for intolerance to GDNT must be documented).
• In the investigator's opinion, willing and able to comply with all study requirements.
• Able to fully understand study information and sign an Institutional Review Board (IRB) approved informed consent (including HIPAA authorization in the U.S.).
Exclusion Criteria:

• Current positive airway pressure use or predominantly obstructive rather than central sleep apnea.
• Oxygen saturation < 90% at rest during the day.
• Nocturnal oxygen saturation < 88% for > 5 continuous minutes unaccompanied by apneas or hypopneas.
• Chronic daytime or nighttime use of supplemental oxygen.
• Participants and their bed-partners who currently smoke in the bedroom.
• Severe pulmonary disease requiring continuous home oxygen therapy or the continuous or frequent intermittent use of oral steroids or documented severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) < 50%.
• Cardiac surgery, percutaneous coronary intervention, myocardial infarction or unstable angina within the previous 3 months.
• Transient ischemic attack or stroke within the previous 3 months.
• Cardiac resynchronization therapy implantation scheduled or performed within 3 months prior to randomization.
• Primary hemodynamically-significant uncorrected valvular heart disease (obstructive or regurgitant) or any valvular disease expected to require surgery during the trial.
• Acute myocarditis/pericarditis or other cause of potentially reversible cardiomyopathy (e.g., post-partum cardiomyopathy, tachycardia-induced cardiomyopathy), within the previous 6 months.
• End-stage (Stage D) heart failure (HF) requiring continuous outpatient intravenous (IV) inotropic therapy, placement of ventricular assist device, listing for cardiac transplantation, or end-of-life care (e.g. hospice care).
• Pregnancy or of child bearing potential without a negative pregnancy test within 10 days prior to enrollment.
• Life expectancy < 1 year for diseases unrelated to chronic HF.
• Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound subject results in this trial.
Heart Failure, Central Sleep Apnea, Heart failure, Systolic (congestive) heart failure, Diastolic (congestive) heart failure, Combined systolic (congestive) and diastolic (congestive) heart failure, Heart failure, unspecified, Heart & Vascular, Lung & Respiratory
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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.
Arterial embolism and thrombosis, Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Failure
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Accelerometer Sensing for Micra AV Study (AccelAV)

The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.
Miguel Leal, MD
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04245345
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Inclusion Criteria:
Subject will be implanted with a MicraTM (Model MC1AVR1) for an approved indication.
• Subject has history of AV block.
• Subject is ≥ 18 years old and as per required local law.
• Subject (and/or witness as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements.
• Subject is willing and able to comply with the protocol.
Exclusion Criteria:

• Subject currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Clinical Research Specialist.
• Subject implanted with a MicraTM (Model MC1AVR1) on a non-permanent basis (e.g. CIED infection).
• Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MicraTM Model MC1AVR1 implant procedures).
• Subject meets any exclusion criteria required by local law (age or other).
Atrial fibrillation and flutter, Heart & Vascular, AV Block, AV Block Complete, 3rd Degree Heart Block, Complete Heart Block
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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
40 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. Participant must be ≥ 40 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, as confirmed by the core laboratory.
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 [PCI] planned after screening Visit 1. Eligible participants who have a PCI planned after screening may be rescreened after the PCI has been performed. 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 (severe) HF. 6. Increased risk of bleeding 1. Patients with history or presence of any bleeding disorder. 2. Active bleeding or high risk for major bleeding (eg, gastrointestinal pathology, malignancy with high risk of bleeding, active peptic ulcer). 3. Need for chronic anticoagulation therapy (prophylactic doses of heparin are allowed). 4. Known severe liver disease (eg, ascites and/or clinical signs of coagulopathy). 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, including but not limited to: 9. Blood pressure (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).
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).
Jason Smith, MD
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) ≤ 25%
• NYHA Class IV heart failure
• Patient is able to provide written informed consent
• More detailed inclusion criteria information is noted in the study protocol
Exclusion Criteria:
The following is a list of general exclusion criteria:
• Active, uncontrolled infection
• Severe end organ dysfunction or failure
• History of any organ transplant
• Prosthetic mechanical aortic valve that will not be converted to a bioprosthesis
• Patients with an unacceptable risk for successful LVAD implantation and maintenance
• Patients refusing blood transfusion
• Intolerant of anticoagulation therapy
• Active psychiatric disorder, irreversible cognitive dysfunction or other psychosocial behavior that impairs the ability of the patient to follow instructions, maintain their device or their medical regimen
• Pregnancy
• Current dependence on other mechanical circulatory support device at the time of implant, other than IABP and Impella 5.0/5.5
• Presence of condition other than heart failure that would limit survival to less than 24 months
• More detailed exclusion criteria information is noted in the study protocol
Cardiomyopathy, Heart Failure
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Dyslipidemia of Obesity Intervention in Teens (DO IT!)

This trial of pitavastatin will determine efficacy and safety in this high risk population and provide evidence for clinicians to target this treatable risk factor to achieve an impact on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular disease.
Amy Peterson
All
10 Years to 19 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02956590
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Inclusion Criteria:

• Boys and girls aged 10 to 19 years (with 2-year availability for study participation)
• BMI ≥85th percentile (using CDC BMI charts)
• Fasting lipid profile x2 each with all of the following:
• LDL-C <160 mg/dL and ≥90 mg/dL, and
• TG <500 mg/dL, and
• TG/HDL-C ratio ≥2.5 or HDL-C <45 mg/dL for boys or HDL-C <50 mg/dL for girls, and
• non-HDL-C ≥120 mg/dL
• Participant consent, or parental/guardian consent and participant assent
Exclusion Criteria:

• Current use of lipid lowering medication, growth hormone, systemic corticosteroids, cyclosporine, protease inhibitors, erythromycin, rifampin, colchicine, warfarin, second generation psychotropic drugs, oral isotretinoin; stable doses of stimulant or antidepressant therapy and antihypertensive medications will be accepted
• Known allergy or hypersensitivity to statin
• Patients who have had bariatric surgery or plan to have bariatric surgery during the trial
• Female who is pregnant, plans to become pregnant or is sexually active without contraception
• Uncontrolled stage 2 hypertension (systolic or diastolic blood pressure ≥95th percentile for age, sex and height percentile + 12 mmHg or ≥140/90, whichever is lower for participants <13 years of age; ≥140/90 for participants ≥13 years of age) confirmed after an appropriate evaluation
• Diabetes (type 1 or type 2) by American Diabetes Association criteria (fasting glucose ≥126 mg/dL, HbA1c ≥6.5%, random glucose ≥200 mg/dL, or 2-hour oral glucose tolerance testing glucose ≥200 mg/dL)
• Use of insulin sensitizing therapy
• Known renal insufficiency (known chronic renal disease, estimated GFR <60 mL/min/1.73m2 at screening)
• Uncontrolled thyroid disease (TSH at screening >1.5x upper limit of normal, clinical or other laboratory evidence of hypothyroidism, or thyroid hormone therapy that has not been stable for 6 weeks prior to screening)
• Proteinuria suggestive of renal disease (more than trace together with an elevated urine protein:creatinine ratio as per local lab)
• Syndromic patients or patients with neurocognitive delay precluding adherence with study drug
• Liver disease other than non-alcoholic fatty liver disease (NAFLD) either diagnosed or suggested by alanine aminotransferase (ALT) ≥ 40 U/L, or severe NAFLD indicated by ALT ≥ 200 U/L
• Unexplained persistent elevated creatine kinase (CK) level >3x upper limit of normal
• Plans to leave the geographic area before completion of the anticipated 2 years of trial participation
• Any unstable medical or emotional condition or chronic disease that would preclude following the protocol or impact valid vascular measurement
• Admits to current smoking, current alcohol consumption
Dyslipidemia, Obesity, Obesity, unspecified, Heart & Vascular, Children's & Adolescent Health, Diabetes, Metabolism & Hormones
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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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