Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation

The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.

Inclusion Criteria:

1. Severe or greater tricuspid valve regurgitation of primary or secondary etiology.
2. NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory.
3. Subject is adequately treated with medical therapy for heart failure >30 days prior to index procedure, including a diuretic.
4. Heart Team determines patient is a recommended candidate for the VDyne System.
5. Age 18 years or older at time of the index procedure.
6. Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.

Exclusion Criteria:

VDYNE SYSTEM SUITABILITY

1. Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs, Sponsor and/or Clinical Screening Committee (CSC)

2. Intolerance to procedural anticoagulation or post-procedural antiplatelet/anticoagulation regimen that cannot be medically managed

3. Hypersensitivity to nickel or titanium

   CLINICAL EXCLUSION CRITERIA (assessed by pre-procedural imaging)

4. Left Ventricular Ejection Fraction (LVEF) <30%

5. Severe RV dysfunction as assessed by the Clinical Screening Committee (CSC).

6. Significant abnormalities of the tricuspid valve and sub-valvular apparatus

7. Sepsis including active infective endocarditis (IE) (within the last 6 months)

8. Right ventricular, atrial thrombus, vegetation or mass on tricuspid valve.

9. Severe tricuspid annular or leaflets calcification

10. Systolic pulmonary hypertension with systolic pulmonary artery pressure >70 mmHg or pulmonary vascular resistance (PVR) >5 wood units as determined by RHC.

11. History of rheumatic fever that impacts the native tricuspid valve or surrounding structures.

    CONCOMITANT PROCEDURES

12. Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease (CAD).

13. Any planned surgery or interventional procedure within 30 days prior to or following the implant procedure. This includes any planned concomitant cardiovascular procedure [e.g. Coronary Artery Bypass Grafting (CABG), percutaneous coronary intervention (PCI), pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.]

14. Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound)

15. Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.

16. Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.

17. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.

18. Prior tricuspid valve surgery or catheter-based therapy with permanent residual device(s) implanted that would preclude delivery or implantation of the VDyne Valve (e.g. valve replacement, edge to edge repair, etc.)

19. Significant valvular heart disease requiring intervention other than the tricuspid valve

20. Known significant intracardiac shunt [e.g. septal defect), patent foramen ovales (PFOs) without significant shunts are allowed]

    COMORBIDITIES

21. Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure

22. Severe lung disease [severe chronic obstructive pulmonary disease (COPD) or continuous use of home oxygen or oral steroids]

23. Acute myocardial infarction (AMI) within 30 days

24. Significant renal dysfunction (eGFR<30 ml/min/1.73m2) or on dialysis

25. End-stage liver disease (MELD > 11 and Child-Pugh class C)

26. Bleeding requiring transfusion within 30 days

27. Coagulopathy or other clotting disorder that cannot be medically managed

28. Chronic immunosuppression or other condition that could impair healing response

29. Any of the following: leukopenia, chronic anemia [Hemoglobin (Hgb) < 9], current thrombocytopenia (platelets <70), history of bleeding diathesis, or coagulopathy

30. Unwilling to receive blood products GENERAL EXCLUSION CRITERIA

31. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically

32. Life expectancy less than 12 months due to non-cardiac comorbidities

33. Treatment is not expected to provide benefit (futile)

34. Current IV Drug user (must be free drug abuse for > 1 year)

35. Pregnant, lactating or planning pregnancy during the course of the study

36. Vulnerable patient groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate, such as students, residents, and employees)

37. Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study

38. Patient (or legal guardian) unable or unwilling to provide written informed consent before study-specific procedures are conducted

39. Patient unable or unwilling to comply with study required testing and follow-up visits.