Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
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, Healthy Volunteers, Supervision of high risk pregnancy, Other
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
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
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
0 Years 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, Other
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.
Girma Tefera
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.
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)
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
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
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension (UNISUS)
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in
prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or
mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH)
compared to macitentan 10 mg.
James Runo, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04273945
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Inclusion Criteria:
• Target population: greater than or equal to (>=) 18 (or the legal age of consent in
the jurisdiction in which the study is taking place) years of age
• Target population: Symptomatic Pulmonary Arterial Hypertension (PAH) in World Health
Organization Functional Class (WHO FC) II, III, or IV
• Target population: PAH subtype falling in one of the below classifications:
Idiopathic; Heritable; Drug- or toxin-induced; Related to: Connective tissue disease,
HIV infection, Portal hypertension, and Congenital heart disease with
small/coincidental cardiac defect with systemic-to-pulmonary shunt (for example atrial
septal defect, ventricular septal defect, patent ductus arteriosus, atrioventricular
septal defect) which does not account for the elevated pulmonary vascular resistance
(PVR) or persistent PAH documented by an Right heart catheterization (RHC) >= 1 year
after simple systemic-to pulmonary shunt repair
• PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to
screening: Mean pulmonary artery pressure (mPAP) greater than (>) 20 millimeters of
mercury (mm Hg), and; Pulmonary artery wedge pressure (PAWP) or left ventricular end
diastolic pressure (LVEDP) less than or equal to (<=) 15 mm Hg, and PVR >= 3 Wood
Units (that is, >= 240 dyn*sec/cm^5)
• Able to perform the 6-minute walking test (6MWT) with a minimum distance of 50 meters
(m) and maximum distance of 440m at screening. Participants able to walk more than
440m at screening are eligible if they are in WHO FC III or IV and n-terminal
prohormone of brain natriuretic peptide or n-terminal pro B-type natriuretic peptide
(NT-proBNP) level is >=300 nanograms per liter (ng/L) at screening, based on central
laboratory results
Exclusion Criteria:
• Known presence of three or more of the following risk factors for heart failure with
preserved ejection fraction at screening, based on records that confirm documented
medical history: Body mass index (BMI) > 30 kilograms per meter square (kg/m^2),
Diabetes mellitus of any type, Essential hypertension (even if well controlled);
Coronary artery disease, that is, any of the following: history of stable angina, or
known more than 50 percent (%) stenosis in a coronary artery, or history of myocardial
infarction, or history of or planned coronary artery bypass grafting and/or coronary
artery stenting
• Presence of moderate or severe obstructive lung disease (forced expiratory volume in 1
second [FEV1] / forced vital capacity [FVC] < 70%; and FEV1 < 60% of predicted after
bronchodilator administration) ) in participants with a known or suspected history of
significant lung disease as documented by a spirometry test performed within 1 year
prior to screening
• Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based
on records that confirm documented medical history
• Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >
1.5*upper limit of normal (ULN) at screening
• Hemoglobin < 100 gram per liter (g/L) (< 10 gram per deciliter [g/dL]) at screening
Pulmonary Arterial Hypertension, Other pulmonary heart diseases, Other
The purpose of the Registry is to provide continuing evaluation and periodic reporting of
safety and effectiveness of Medtronic market-released products. The Registry data is intended
to benefit and support interests of patients, hospitals, clinicians, regulatory bodies,
payers, and industry by streamlining the clinical surveillance process and facilitating
leading edge performance assessment via the least burdensome approach.
Micah Chan
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT01524276
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Inclusion Criteria:
• Patient or legally authorized representative provides written authorization and/or
consent per institution and geographical requirements
• Patient has or is intended to receive or be treated with an eligible Medtronic product
• Patient within enrollment window relative to therapy initiation or meets criteria for
retrospective enrollment
Exclusion Criteria:
• Patient who is, or will be, inaccessible for follow-up
• Patient with exclusion criteria required by local law
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or
device study that may confound results
Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders, Digestive Disorders, Intracranial Aneurysm, Mechanical Circulatory Support, Respiratory Therapy, Aortic, Peripheral Vascular and Venous Disorders, Minimally Invasive Surgical Procedures, Diagnostic Techniques and Procedures, Surgical Procedures, Operative, Renal Insufficiency, Neurovascular, Coronary Artery Disease, Ear, Nose and Throat Disorder, Other
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.
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, Ph.D.
All
18 Years and over
N/A
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 intravenous (IV) conscious sedation for imaging are not
eligible; patients requiring mild, oral anxiolytics for research imaging will be
allowed to participate as long as:
• The participants has their own prescription for the medication;
• The informed consent process is conducted prior to the self-administration of this
medication; and,
• The participant comes to the research visit with a driver
• 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, Other
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).
Yu Xia
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
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 65 additional subjects may be implanted in Continued Access Phase under 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 65 additional
subjects implanted in Continued Access (Primary Study arm)
Dai Yamanouchi
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
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.
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
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, or current European Society of Cardiology (ESC) guidelines for HF treatment in
Europe, 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 ACE-I, ARB, 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 significant congenital heart disease that has not been repaired and
would prevent implantation of the Cordella PA sensor 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 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 Failure NYHA Class III, Other, Heart & Vascular, Aging & Geriatrics
Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (EPIK-P2)
This is a prospective Phase II multi-center study with an upfront 16-week, randomized,
double-blind, placebo-controlled period, and extension periods, to assess the efficacy,
safety and pharmacokinetics of alpelisib in pediatric and adult participants with
PIK3CA-related overgrowth spectrum (PROS).
Beth Drolet, MD
All
2 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04589650
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Inclusion Criteria:
1. Signed informed consent and assent (when applicable) from the patient, parent, legal
authorized representative or guardian prior to any study related screening procedures
are performed
2. Patients with diagnosis of PROS with symptomatic and /or progressive overgrowth and at
least one measurable PROS-related lesion confirmed by blinded independent review
committee (BIRC) assessment
3. Documented evidence of a somatic mutation(s) in the PIK3CA gene performed in local
laboratories
4. A tissue sample (fresh or archival) is be sent to a Novartis-designated central
laboratory. If archival tissue is not available, collection of a fresh tissue biopsy
is required for participants in Groups 1, 2 and 5, if it is not clinically
contraindicated. For participants in Groups 3 and 4, a fresh tissue biopsy is not
mandatory.
For China only: Tissue sample collection and biomarker assessments are not applicable.
For Germany only: If archival tissue is available, it must be sent to a Novartis
designated central laboratory. If no archival tissue is available, obtaining a fresh
tissue biopsy is recommended, if it is not clinically contraindicated, but is not
mandatory.
5. Karnofsky (in patients > 16 years old at study entry)/Lansky (≤16 yrs of age at study
entry) performance status index ≥50
6. Adequate bone marrow and organ function including Fasting plasma glucose (FPG) ≤ 140
mg/dL (7.7 mmol/L) and Glycosylated hemoglobin (HbA1c) ≤ 6.5% (both criteria have to
be met) (as assessed by central laboratory for eligibility)
7. Presence of at least one PROS-related measurable lesion defined as a lesion with
longest diameter ≥2 cm, when the volume can be accurately and reproducibly measured by
MRI (Magnetic resonance imaging), and associated with complaints, clinical symptoms or
functional limitations affecting the patient's everyday life. Measurability must be
confirmed by BIRC before randomization.
Exclusion Criteria:
1. Participant with only isolated macrodactyly, skin nevus/nevi and macroencephaly (the
only clinical feature or a combination of any of three of them), in absence of other
PROS-related lesions at the time of informed consent
2. Previous treatment with alpelisib and/or any other PI3K inhibitor(s) (except treatment
attempt, defined as the attempt to treat PROS with any of PI3K inhibitors, with
treatment duration less than 2 weeks and stopped at least 4 weeks prior to the first
dose of study medication with alpelisib)
3. Radiation exposure for PROS treatment purpose within the previous 12 months on those
PROS areas which are expected to qualify for target lesions (except lesion(s)
progressing after completion of radiotherapy) at time of informed consent.
4. Debulking or other major surgery performed within 3 months at time of informed consent
5. Clinically meaningful PROS-related thrombotic event (Grade 2 and more as per CTCAE
v.4.03) within 30 days before informed consent, and/or sclerotherapy/embolization for
vascular complications performed within 6 weeks before informed consent. Note:
Participants receiving anticoagulants for PROS-related coagulopathy, primary or
secondary prophylaxis of thrombosis may be included in the study
6. Participants in Groups 1, 2 ad 5 with documented pneumonitis or interstitial lung
disease at time of informed consent and with impaired lung function (e.g., FEV1 or
DLCO ≤ 70% of predicted) that is not related to PROS. Participants in Groups 3 and 4
with documented or suspicious pneumonitis or interstitial lung disease based on MRI
images at time of informed consent
7. History of acute pancreatitis within 1 year before informed consent or past medical
history of chronic pancreatitis at time of informed consent
8. Participants with an established diagnosis of type I diabetes mellitus or uncontrolled
type II diabetes mellitus at time of informed consent
9. Known history of seizure, or epilepsy, regardless of relatedness to PROS spectrum at
time of informed consent, when epilepsy is not controlled and/or the patient may not
be switched to non-enzyme inducing antiepileptic drug(s) at time of informed consent.
10. Participants with clinically significant worsening of PROS-related laboratory
anomalies, physical signs and symptoms (such as, but not limited to increase of
D-dimers, worsening of underlying pain, newly occurring swelling or redness)
indicating an uncontrolled condition during the screening phase, particularly if
systemic treatment with any other inhibitor of the PI3K/AKT/mTOR pathway was stopped
prior to the start of study treatment. This includes but is not limited to
hypercoagulability state in participants not receiving prophylactic treatment.
Other inclusion/exclusion criteria may apply
COVID Protection After Transplant-Immunosuppression Reduction (CPAT-ISR)
This study will enroll individuals who have:
- Completed primary series of mRNA COVID-19 vaccine, and
- An antibody response ≤ 2500 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. Individual ≥18 years of age.
3. Recipient of a kidney or liver transplant ≥12 months prior to enrollment, without
allograft rejection in the 6 months preceding enrollment
4. Negative for anti-donor human leukocyte antigens (HLA) antibodies at screening
(Central Lab Test Determination).
5. Currently taking one of the following tacrolimus-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
6. Received a minimum of 3 doses of either the Moderna coronavirus infectious disease 19
(COVID-19) vaccine or Pfizer-BioNTech COVID-19 vaccine
7. Participant must be ≥ 60 days after completion of primary vaccination or receipt of
the most recent booster dose with any authorized or approved monovalent or bivalent
COVID-19 vaccine at the time of study vaccine.
8. Serum antibody negative or low (titer ≤ 2500 U/mL) at ≥ 30 days from the last dose of
mRNA COVID-19 vaccine and ≥ 30 days following receipt of a monoclonal antibody product
or convalescent plasma for COVID-19, measured using the Roche Elecsys® anti-SARS-CoV-2
S assay.
9. 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. Prior receipt of the Moderna COVID-19 Vaccine 2023-2024 or Pfizer-BioNTech COVID-19
Vaccine 2023-2024.
6. Currently taking any systemic immunosuppressive agent, other than their prescribed
transplant immunosuppression
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.
Complications of transplanted organs and tissue, Other immunodeficiencies, Other, Transplant, Kidney Transplant Recipients, Liver Transplant Recipients
A phase 3 randomized partial blind storage duration ranging study in patients undergoing
complex cardiac surgery that will compare the transfusion of cold stored platelets to
standard room temperature stored platelets. The primary objective is to establish that cold
stored platelets have a non-inferiority (or superiority) to room temperature platelets.
Eric Simon
All
29 Days to 84 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04834414
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Inclusion Criteria:
• Age greater than 28 days and less than 85 years
• Planned complex cardiac surgery with planned use of cardiopulmonary bypass
Exclusion Criteria:
• Expected order for washed or volume reduced platelets
• Patient with known anti-platelet antibodies
• Platelet transfusion refractoriness due to anti-HLA antibodies
• Known or suspected pregnancy
• Previously randomized in this study
• Conscious objection or unwillingness to receive blood products
• Known IgA deficiency
• Known congenital platelet disorder
• Known congenital bleeding disorder
• Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist
device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis
• Patients intended to receive whole blood either intra-operative or post-operative for
bleeding
• Platelet transfusion (of any type) within 24 hours prior to the date of surgery
• Pre-operative thrombocytopenia, defined as platelet count <75x10(9)/L, based on the
most recent labs completed within 72 hours prior to the date of surgery.
Acute Blood Loss, Complications of heart transplant, Congenital malformation of heart, unspecified, Heart failure, Other acute ischemic heart diseases, Other, Heart & Vascular
A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects
This is a randomized, double-blind, placebo controlled, multicenter study to compare the
efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for
congenital heart defects. Eligible patients undergoing repair of a large unrestrictive
ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD),
or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment.
Petros Anagnostopoulos
All
up to 18 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05253209
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Inclusion Criteria:
• Patients, parents, or legal guardian willing and able to sign informed consent
• Male and female subjects aged ≤18 years of age (females of child-bearing potential
willing to practice an acceptable form of birth control)
• Patients undergoing cardiopulmonary bypass for repair of a large unrestrictive
ventricular septal defect, an ostium primum/secundum atrial septal defect, or a
partial or complete atrioventricular septal defect
• Pre-operative echocardiogram confirming cardiovascular anatomy and defect to be
repaired
Exclusion Criteria:
• Evidence of pulmonary artery or vein abnormalities that will not be addressed
surgically. Specific abnormalities excluded include:
• significant pulmonary artery narrowing not amenable to surgical correction
• previous pulmonary artery stent placement
• significant left sided AV valve regurgitation not amenable to surgical correction
• pulmonary venous return abnormalities not amenable to surgical correction
• pulmonary vein stenosis not amenable to surgical correction
• Preoperative requirement for mechanical ventilation or IV inotrope support
• Presence of fixed or idiopathic pulmonary hypertension (i.e. Eisenmenger's Syndrome)
prior to surgical repair
• Pre-operative use of medications to treat pulmonary hypertension
• Pregnancy; Sexually active females of child-bearing potential must be willing to
practice an acceptable method of birth control for the duration of study participation
(e.g. oral contraceptive, hormonal implant, intra-uterine device)
• Participation in another clinical trial within 30 days of Screening or while
participating in the current study, including the 28 days of follow-up post study drug
administration.
• Any condition which, in the opinion of the investigator, might interfere with the
study objectives
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA)
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death.
Azam Ahmed, MD
All
30 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05047172
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Inclusion Criteria:
• Acute focal symptoms or signs of any duration associated with imaging, pathological,
or other objective evidence of arterial infarction OR clinical evidence of cerebral,
spinal cord, or retinal focal arterial ischemic injury based on symptoms persisting
greater than or equal to 24 hours that occurred within 30 days prior to randomization
• Index stroke is attributed to 70-99% stenosis (or flow gap on MRA) of a major
intracranial artery (carotid artery, middle cerebral artery (M1 or M2), vertebral
artery (V4), basilar artery, posterior cerebral artery (P1), or anterior cerebral
artery (A1)) documented by CTA, MRA, or catheter angiography
• Modified Rankin Scale score of ≤ 4, at time of consent
• Ability to swallow pills
• At least 30 years of age, inclusive, at time of consent
• Subjects 30-49 years of age are required to meet at least ONE of the following
additional criteria below to qualify for the study:
1. diabetes treated with insulin for at least 15 years
2. at least 2 of the following atherosclerotic risk factors: hypertension (BP >
140/90 or on antihypertensive therapy); dyslipidemia (LDL > 130 mg /dl or HDL <
40 mg/dl or fasting triglycerides > 150 mg/dl or on lipid lowering therapy);
smoking; non-insulin dependent diabetes or insulin dependent diabetes of less
than 15 years duration; any of the following vascular events occurring in a
parent or sibling who was < 55 years of age for men or < 65 years of age for
women at the time of the event: myocardial infarction, coronary artery bypass,
coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting,
peripheral vascular surgery for atherosclerotic disease
3. personal history of any of the following: myocardial infarction, coronary artery
bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or
peripheral vascular surgery for atherosclerotic disease
4. any stenosis of an extracranial carotid or vertebral artery, another intracranial
artery, subclavian artery, coronary artery, iliac or femoral artery, other lower
or upper extremity artery, mesenteric artery, or renal artery that was documented
by non-invasive vascular imaging or catheter angiography and is considered
atherosclerotic
5. aortic arch atheroma documented by non-invasive vascular imaging or catheter
angiography
6. any aortic aneurysm documented by non-invasive vascular imaging or catheter
angiography that is considered atherosclerotic
• Negative pregnancy test in a female who has had any menses in the last 18 months and
has not had surgery that would make her unable to become pregnant
• Subject is willing and able to return for all follow-up evaluations required by the
protocol
• Subject is available by phone
• Subject understands the purpose and requirements of the study and can make him/herself
understood
• Subject has provided informed consent (use of a LAR is not permitted)
Exclusion Criteria:
• Previous treatment of target lesion with a stent, angioplasty, or other mechanical
device, including mechanical thrombectomy for the qualifying stroke, or plan to
perform one of these procedures
• Plan to perform concomitant endarterectomy, angioplasty or stenting of an extracranial
vessel tandem to the symptomatic intracranial stenosis
• Intracranial tumor (except meningioma) or any intracranial vascular malformation
• Thrombolytic therapy within 24 hours prior to randomization
• Progressive neurological signs within 24 hours prior to randomization
• History of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural)
• Intracranial arterial stenosis due to: arterial dissection; MoyaMoya disease; any
known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy;
neurosyphilis; any other intracranial infection; any intracranial stenosis associated
with CSF pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle
cell disease; neurofibromatosis; benign angiopathy of central nervous system;
postpartum angiopathy; suspected vasospastic process; reversible cerebral
vasoconstriction syndrome (RCVS); suspected recanalized embolus
• Presence of any of the following unequivocal cardiac sources of embolism: chronic or
paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis,
intracardiac clot or vegetation, myocardial infarction within three months, left
atrial spontaneous echo contrast
• Known allergy or contraindication to aspirin, rivaroxaban, clopidogrel, or ticagrelor
• Uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure
> 115 mm Hg), active peptic ulcer disease, major systemic hemorrhage within 30 days
prior to randomization, active bleed or bleeding diathesis, platelets < 100,000,
hematocrit < 30, INR > 1.5, clotting factor abnormality that increases the risk of
bleeding, current alcohol or substance abuse, severe liver impairment (AST or ALT > 3
x normal, cirrhosis), or CrCl < 15 mL/min or on dialysis
• Major surgery (including stenting of any vessel; open femoral, aortic, or carotid
surgery; or cardiac surgery) within previous 30 days prior to randomization or planned
in the next 90 days after randomization
• Any condition other than intracranial arterial stenosis that requires the subject to
take any antithrombotic medication other than aspirin (NOTE: exceptions allowed for
subcutaneous heparin for deep vein thrombosis (DVT) prophylaxis)
• Dementia or psychiatric problem that prevents the subject from following an outpatient
program reliably
• Co-morbid conditions that may limit survival to less than 12 months
• Pregnancy or of childbearing potential and unwilling to use contraception for the
duration of this study, or currently breastfeeding
• Current or anticipated concomitant oral or intravenous therapy with strong CYP3A4
inhibitors or CYP3A4 substrates that cannot be stopped for the course of this study
• Enrollment in another study that would conflict with the current study
A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive HCM) (DISCOVER-HCM)
The purpose of this study is to evaluate the safety of mavacamten in patients with
symptomatic obstructive hypertrophic cardiomyopathy (HCM) treated in the real-world setting.
The registry study also provide a real-world understanding of the current obstructive HCM
patient population, treatment patterns, and clinical relevant outcomes for patients with
symptomatic obstructive HCM in the US.
Aurangzeb Baber
All
18 Years and over
IV
This study is NOT accepting healthy volunteers
NCT05489705
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Inclusion Criteria:
1. Willing and able to provide written informed consent form (ICF) and any required
privacy authorization prior to the initiation of study procedures. i. Diagnosis of
obstructive HCM consistent with 2020 American Heart Association/American College of
Cardiology (AHA/ACC) guidelines. ii. Obstructive HCM is defined clinically by the
presence of increased LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family
history of HCM) in a nondilated ventricular chamber that is not solely explained by
abnormal loading conditions (eg, another cardiac or systemic disease) and peak LVOT
gradient of
≥ 30 mmHg at rest or with provocation.
2. Has documented LVEF of ≥ 55% recorded by echocardiography within the last 6 months.
3. Symptoms consistent with NYHA functional class II-IV.
4. ≥ 18 years of age at the time of informed consent.
5. Receiving BBs, non-dihydropyridine calcium. channel blockers (non-DHP CCBs),
disopyramide, and/or mavacamten (once available) as part of routine clinical care; or
currently receiving no treatment due to intolerance or failure of prior treatment (eg,
BBs, non-DHP CCBs, or disopyramide) for obstructive HCM.
Exclusion Criteria:
1. Known phenocopy disease (eg, Fabry disease, amyloidosis) or LV hypertrophy associated
with hypertension.
2. Documentation of any fixed obstruction of the outflow tract such as aortic valve
stenosis or replacement.
3. Prior treatment of obstructive HCM with invasive septal reduction (surgical myectomy
or percutaneous alcohol septal ablation [ASA]) within 6 months prior to enrollment;
participants with an unsuccessful myectomy or percutaneous ASA performed > 6 months
prior to enrollment may be enrolled.
4. Naïve to treatment for obstructive HCM (ie, never treated with BBs, non-DHP CCBs, or
disopyramide).
5. Receiving an investigational therapeutic agent for obstructive HCM (eg,
myosin-inhibitors other than mavacamten) in an interventional clinical trial at
participant enrollment.
6. Previously or currently enrolled in a long-term safety extension study of mavacamten
(eg, EXPLORER-HCM [ClinicalTrials.gov, NCT03470545], MAVA-LTE [NCT03723655],
PIONEER-OLE [NCT03496168], VALORHCM [NCT04349072], or MAVERICK [NCT03442764])
The goal of this observational study is to determine the feasibility of renal Near Infrared
Spectroscopy (NIRS) monitoring in the newborn nursery for newborns at low risk of coarctation
of the aorta (CoA). The main questions it aims to answer are:
- whether continuous renal NIRS monitoring is feasible;
- whether NIRS monitoring results in higher nursing and parent/caregiver satisfaction than
current standard monitoring; and,
- whether participants who develop CoA will spend a smaller proportion of time within the
normal range than patients who do not have CoA.
Participants will be observed through continuous renal oxygenation monitoring with NIRS.
Matthew Harer, MD
All
15 Years and over
Pilot/Feasibility
This study is NOT accepting healthy volunteers
NCT05842876
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Neonate
Inclusion Criteria:
• Delivered at ≥ 35 weeks of gestation
• <12 hours of age
• Inpatient at Meriter Hospital, Inc. NICU or Newborn Nursery or AFCH PICU or NICU
• Diagnosed as at risk for CoA
Neonate
Exclusion Criteria:
• Major congenital anomalies of the kidney
• Attending physician's discretion to not place sensors due to clinical concerns
• In the researcher's medical opinion, there is a significant likelihood that the
neonate would not survive the first 3 days of life
Primary Caregiver
Inclusion Criteria:
• Able to understand and the willing to sign a written informed consent document
• Willing to comply with all study procedures and be available for the duration of the
study
• Birth parent (i.e., the parent who gave birth to the baby) who is the primary
caregiver of a neonate who is eligible to participate in study
• Agrees to enroll neonate into study
• Aged 15 years or older
• Pregnant mother with a baby diagnosed prenatally as at risk for CoA will be eligible
for the study. They must also meet the following criteria:
• Require an "arch watch care plan" as a results of prenatal ultrasonography findings
• Agree to enroll offspring into the study at birth
Primary Caregiver
Exclusion Criteria:
• Subject is unable to provide informed consent, including subjects who are in foster
care and subjects within state custody
• Pregnant woman who does not plan to maintain custody of the child after birth, such as
instances of adoption or surrogacy
Newborn Nursery Nursing Staff:
• All Newborn Nursery nursing staff at Meriter Hospital, Inc.'s Newborn Nursery are
eligible to participate
The ACCEL® Absorbable Hemostat Powder Clinical IDE Trial is designed as a prospective,
multi-center, randomized, non-inferiority, controlled pivotal clinical trial to evaluate the
safety and efficacy of the ACCEL® Absorbable Hemostat Powder as compared to gelatin sponge,
for achieving hemostasis in subjects undergoing cardiovascular, liver, or soft tissue
surgery, when control of oozing to moderate bleeding by standard surgical techniques is
ineffective and/or impractical.
Chris Rokkas
All
22 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04728087
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Inclusion Criteria:
Pre-Surgery:
1. Subject is greater than or equal to 22 years old
2. Subject is undergoing a cardiovascular surgery, liver surgery or soft tissue surgical
procedure
3. Subject is willing and able to provide appropriate (Institutional Review Board (IRB)
approved) informed consent.
4. The subject is willing and able to comply with the requirements of the protocol,
including follow-up evaluations and schedule.
5. The subject is willing to be treated with ACCEL® Absorbable Hemostat Powder
6. The subject is willing to be treated with a commercially available absorbable gelatin
sponge
During Surgery:
7. Subject has not received blood transfusions between screening and application of
investigational product or commercially available absorbable gelatin sponge
8. There is an estimated TBS surface area of ≤ 60 cm2
9. Visual observation of oozing (0.01 g/10s ˂ Flow ˂ 0.04 g/10s), mild (0.04 g/10s ≤ Flow
˂ 0.32 g/10s), or moderate (0.32 g/10s ≤ Flow ˂ 1.01 g/10s) bleeding as validated and
when control by conventional surgical techniques, including but not limited to suture,
ligature and cautery, is ineffective and/or impractical
10. There is an absence of intra-operative complications other than bleeding, which, in
the opinion of the Investigator, may interfere with the assessment of efficacy or
safety
11. There has been no intra-operative use of adjunct hemostat(s) on the target bleeding
site identified for application of the study treatment
Exclusion Criteria:
Pre-Surgery:
1. The subject is pregnant (verified in a manner consistent with institution's standard
of care)
2. Subject is lactating
3. Subject is currently participating in another investigational device or drug trial or
has participated in one in the past 4 weeks (prior to surgery) or is planning to
participate in another research study involving any investigational product within 4
weeks after surgery
4. Subject is a prisoner, a minor or unable to adequately give informed consent due to
mental or physical condition
5. Subject has medical, social, or psychosocial issues that the Investigator believes
could impact the subject's safety or compliance with study procedures
6. Subject has a known allergy to potatoes
7. Subject has a known allergy to porcine collagen/gelatin
8. Subject has a religious or other objection to porcine products
9. Subject is unwilling to receive blood products
10. Subject has history of heparin-induced thrombocytopenia (only for cardiovascular
subjects where heparin use is required)
11. Subject with a baseline abnormality of INR > 2.5 or an aPTT> 100 seconds during
screening that is not explained by current drug treatment (e.g. heparin, warfarin,
etc.).
12. Subjects with platelets < 100 X 109 PLT/L during screening
13. Subject with Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) > 3 X
upper limit normal range during screening, except for subjects undergoing liver
resection surgery or with a diagnosis of liver metastases where there is no upper
limit normal for these analytes due to the nature of their disease
14. Subject is unwilling or unable to return for the required follow-up after surgery
During Surgery:
15. Subject has an operative bleeding site which the surgeon is unable or unwilling to
control with a hemostatic agent
16. Extracorporeal cardiopulmonary bypass circuits or blood salvage circuits are to be
used during or after identification of the TBS.
17. There has been intra-operative use of thrombin on the patient.
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation (REACT-AF)
REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE
design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct
Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing
Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial
Fibrillation (AF) and low-to-moderate stroke risk.
Jennifer Wright
All
22 Years to 85 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05836987
Show full eligibility criteria
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Inclusion Criteria:
1. Male or female, 22-85 years of age.
2. English speaking participants*
3. Documented history of symptomatic or asymptomatic paroxysmal or persistent AF. The
duration of AF must have been > 30 seconds as documented by an external monitor or
present on 12-lead ECG.
4. CHA2DS2-VASC score of 1-4 without prior stroke or Transient Ischemic Attack (TIA)**
5. The participant is on a DOAC at the time of screening.
6. Willing and able to comply with the protocol, including:
• Possession of a smartwatch-compatible smartphone (iPhone that supports the latest
shipping iOS) with a cellular service plan
• Be willing to wear the Apple watch at least 14 hours a day
• Expected to be within cellular service range at least 80% of the time
7. Willing and able to discontinue DOAC
8. The participant is willing and able to provide informed consent.
Exclusion Criteria:
1. Valvular or permanent atrial fibrillation.
2. Current treatment with warfarin and unwilling or unable to take a DOAC.
3. The participant is a woman who is pregnant, nursing, or of child-bearing potential and
is not on birth control.
4. The participant is being treated with chronic aspirin, another anti-platelet agent, or
chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention
in patients with atrial fibrillation, primary prevention of cardiovascular events,
pain relief, fever, gout) and is unwilling or unable to discontinue use for the study
duration.
5. Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable
Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or
planned insertable cardiac monitor.
6. Any documented single AF episode lasting ≥ 1 hour on screening external cardiac
monitor of >=6 days duration.
7. Mechanical prosthetic valve(s) or severe valve disease.
8. Hypertrophic cardiomyopathy.
9. Participant needs Direct Oral Anticoagulation (DOAC) for reasons other than preventing
stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis
(DVT) or Pulmonary Embolism (PE)) or needs permanent Oral Anticoagulant (OAC) (i.e.,
congenital heart defects, prosthetic heart valve).
10. Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid
artery disease defined as stenosis > 75%) based on the investigator's discretion.
11. The participant is enrolled, has participated within the last 30 days, or is planning
to participate in a concurrent drug and/or device study during the course of this
clinical trial. Co-enrollment in concurrent trials is only allowed with documented
pre-approval from the study manager; there is no concern that co-enrollment could
confound the results of this trial.
12. The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area
on the ipsilateral side that the AFSW may be worn.
13. The participant has a tremor on their ipsilateral side that the AFSW may be worn.
14. Any concomitant condition that, in the investigator's opinion, would not allow safe
participation in the study (e.g., drug addiction, alcohol abuse).
15. Known hypersensitivity or contraindication to direct oral anticoagulants.
16. Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.
17. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated
hyperthyroidism). AF ablation does not constitute reversible AF.
18. > 5% burden premature atrial or ventricular depolarizations on any given calendar day
on pre-enrollment cardiac monitoring.
19. History of atrial flutter that has not been treated with ablation (participants in
atrial flutter and have been ablated are eligible for enrollment).
20. Stage 4 or 5 chronic kidney disease.
21. Conditions associated with an increased risk of bleeding:
• Major surgery in the previous month
• Planned surgery or intervention in the next three months.
• History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic
intra-articular bleeding
• Gastrointestinal hemorrhage within the past year unless the cause has been
permanently eliminated (e.g., by surgery)
• Symptomatic or endoscopically documented gastroduodenal ulcer disease in the
previous 30 days
• Hemorrhagic disorder or bleeding diathesis
• Need for anticoagulant treatment for disorders other than AF
• Required use of non-aspirin antiplatelet agents (i.e., Plavix) at time of
enrollment
• Uncontrolled hypertension (Systolic Blood Pressure (SBP) >180 mmHg and/or
Diastolic Blood Pressure( DBP) >100 mmHg)
• Spanish-only speakers may be included in the future at select sites where
consent forms are appropriately translated.
• Congestive heart failure defined as: The presence of signs and symptoms
of either right (elevated central venous pressure, hepatomegaly,
dependent edema) or left ventricular failure (exertional dyspnea,
cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac
enlargement, rales, gallop rhythm, pulmonary venous congestion) or
both, confirmed by non-invasive or invasive measurements demonstrating
objective evidence of cardiac dysfunction and/or ejection fraction <
40%
*Note: Email is generally not a secure way to communicate sensitive or health-related information as there are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed personal information by email.