Status:
WITHDRAWN
Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation
Lead Sponsor:
Boston Biomedical Associates
Collaborating Sponsors:
Cardiovalve Ltd.
Cardiovascular Research Foundation, New York
Conditions:
Tricuspid Regurgitation
Eligibility:
All Genders
18-84 years
Phase:
NA
Brief Summary
This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral System for tricuspid valve replacement. Data collected in the clinical study will include 30-day safety a...
Detailed Description
The Cardiovalve Transfemoral System for tricuspid valve replacement Data collected in the clinical study will include 30-day safety and performance of the device and delivery system, and long-term cl...
Eligibility Criteria
Inclusion
- Participant is 85 ≥ Age ≥ 18 years
- Participant has severe, symptomatic tricuspid regurgitation (TR) ≥ 3+ based upon echocardiography, as assessed by Independent core laboratory
- Participant is New York Heart Association (NYHA) Class II-IVa
- Participant has left ventricular ejection fraction (LVEF) ≥ 35%
- Participant distance of 6 minute walk test (6MWT) ≥ 60 m
- Participant adequately treated based upon medical standards, including for coronary artery disease, mitral regurgitation and Guideline Directed Medical Therapy (GDMT) for heart failure for at least 30-days prior to index procedure.
- Acceptable by the site "Heart Team" including an interventional cardiologist, cardiothoracic surgeon, heart failure cardiologist and recommended as a candidate for the Cardiovalve System
- Participant approved by the Subject Screening Committee
Exclusion
- Known significant intracardiac shunt (e.g. septal defect) or congenital structural heart disease (PFO's without significant shunts are allowed)
- Significant coronary artery disease requiring treatment
- Primary tricuspid disease (e.g. rheumatic, myxomatous degeneration, tricuspid valve prolapse)
- Severe right ventricular failure per ASE guidelines1
- Systolic pulmonary arterial pressure \> 65 mmHg as assessed by transthoracic echocardiography
- Presence of any known life threatening non-cardiac disease that will limit the subject's life expectancy to less than one year
- Cerebrovascular event (stroke, TIA) within the past 3 months
- Active endocarditis or history of mitral/tricuspid endocarditis within the last 12 months
- Patient has significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis)
- Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count \<90k)
- Documented evidence of significant renal dysfunction (eGFR\<30 ml/min/1.73m2) or on any form of dialysis at time of screening within the last 4 weeks
- Contraindication or known allergy to device's components, to anti-coagulation therapy with vitamin K antagonists or to contrast media that cannot be adequately premedicated
- Patients unsuitable for implantation because of thrombosis of the lower venous system or presence of a vena cava filter
- The patient has contraindication against a transesophageal echo (TEE) during the procedure
- Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)
- Hepatic insufficiency (MELD \> 10)
- Female patient of child-bearing potential
- Psychiatric or behavioral disease including known alcohol or drug abuser that is likely to impair compliance with protocol
- Requirement for Antibiotic Treatment within the last 48 hours
- Cardiac Anatomy deemed not suitable for the Cardiovalve Implant
- Surgical or interventional procedure planned within 30 days prior to index procedure
- UNOS Status 1 heart transplant or prior orthotropic heart transplantation.
- Any prior Tricuspid valve surgery or transcatheter Tricuspid valve procedure
- Modified Rankin Scale \> 4 disability
- Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within one month prior to index procedure
- Need for any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of index procedure
- Currently participating in an investigational drug or another device study which has not reached its primary endpoint
- Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment
- Chronic oral steroid or other condition that could impair healing response (e.g. cardiac sarcoidosis or other chronic inflammatory disease).
- Acutely decompensated heart failure (i.e. hemodynamically unstable or requiring IV inotrope ) at the time of screening
- Severe COPD or continuous use of home oxygen
- Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
- Aortic or pulmonic valve disease requiring surgery
- Venous peripheral anatomy unsuitable for implant delivery
- Chronic anemia (Hgb \< 9)
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2030
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04100720
Start Date
February 1 2024
End Date
December 1 2030
Last Update
August 6 2024
Active Locations (3)
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1
Northwestern University / Bluhm Cardiovascular Institute
Chicago, Illinois, United States, 60611
2
Columbia University Medical Center / NYPH
New York, New York, United States, 10032
3
Montefiore Medical Center
The Bronx, New York, United States, 10461