Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation

NCT ID: NCT04100720

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2030-12-31

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

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 clinical outcomes over a follow-up of 5 years.

Conditions

Tricuspid Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cardiovalve Transfemoral Tricuspid Valve

Replacement (Implant) delivered through a transfemoral access

Group Type: EXPERIMENTAL

Cardiovalve Transfemoral Tricuspid Valve

Intervention Type: DEVICE

The Cardiovalve Transfemoral Tricuspid Valve System is intended for use in patients with severe, symptomatic Tricuspid regurgitation

Interventions

Cardiovalve Transfemoral Tricuspid Valve

The Cardiovalve Transfemoral Tricuspid Valve System is intended for use in patients with severe, symptomatic Tricuspid regurgitation

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiovalve Ltd.

INDUSTRY

Sponsor Role: collaborator

Cardiovascular Research Foundation, New York

OTHER

Sponsor Role: collaborator

Boston Biomedical Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northwestern University / Bluhm Cardiovascular Institute

Chicago, Illinois, United States

Columbia University Medical Center / NYPH

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

CP 19-01

Identifier Type: -

Identifier Source: org_study_id