Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation

Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation

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 and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years.

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 clinical outcomes over a follow-up of 5 years.

Inclusion Criteria:

1. Participant is 85 ≥ Age ≥ 18 years
2. Participant has severe, symptomatic tricuspid regurgitation (TR) ≥ 3+ based upon echocardiography, as assessed by Independent core laboratory
3. Participant is New York Heart Association (NYHA) Class II-IVa
4. Participant has left ventricular ejection fraction (LVEF) ≥ 35%
5. Participant distance of 6 minute walk test (6MWT) ≥ 60 m
6. 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.
7. Acceptable by the site "Heart Team" including an interventional cardiologist, cardiothoracic surgeon, heart failure cardiologist and recommended as a candidate for the Cardiovalve System
8. Participant approved by the Subject Screening Committee

Exclusion Criteria:

1. Known significant intracardiac shunt (e.g. septal defect) or congenital structural heart disease (PFO's without significant shunts are allowed)
2. Significant coronary artery disease requiring treatment
3. Primary tricuspid disease (e.g. rheumatic, myxomatous degeneration, tricuspid valve prolapse)
4. Severe right ventricular failure per ASE guidelines1
5. Systolic pulmonary arterial pressure > 65 mmHg as assessed by transthoracic echocardiography
6. Presence of any known life threatening non-cardiac disease that will limit the subject's life expectancy to less than one year
7. Cerebrovascular event (stroke, TIA) within the past 3 months
8. Active endocarditis or history of mitral/tricuspid endocarditis within the last 12 months
9. Patient has significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis)
10. Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <90k)
11. 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
12. 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
13. Patients unsuitable for implantation because of thrombosis of the lower venous system or presence of a vena cava filter
14. The patient has contraindication against a transesophageal echo (TEE) during the procedure
15. Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)
16. Hepatic insufficiency (MELD > 10)
17. Female patient of child-bearing potential
18. Psychiatric or behavioral disease including known alcohol or drug abuser that is likely to impair compliance with protocol
19. Requirement for Antibiotic Treatment within the last 48 hours
20. Cardiac Anatomy deemed not suitable for the Cardiovalve Implant
21. Surgical or interventional procedure planned within 30 days prior to index procedure
22. UNOS Status 1 heart transplant or prior orthotropic heart transplantation.
23. Any prior Tricuspid valve surgery or transcatheter Tricuspid valve procedure
24. Modified Rankin Scale > 4 disability
25. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within one month prior to index procedure
26. Need for any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of index procedure
27. Currently participating in an investigational drug or another device study which has not reached its primary endpoint
28. Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment
29. Chronic oral steroid or other condition that could impair healing response (e.g. cardiac sarcoidosis or other chronic inflammatory disease).
30. Acutely decompensated heart failure (i.e. hemodynamically unstable or requiring IV inotrope ) at the time of screening
31. Severe COPD or continuous use of home oxygen
32. 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
33. Aortic or pulmonic valve disease requiring surgery
34. Venous peripheral anatomy unsuitable for implant delivery
35. Chronic anemia (Hgb < 9)