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

Inclusion Criteria:

1. Moderate or severe tricuspid valve regurgitation of primary or secondary etiology.

2. Subject is adequately treated with medical therapy for heart failure 30 days priorto index procedure, including a diuretic.

3. Heart Team determines patient is a recommended candidate for the VDyne System.

4. Age 18 years or older.

5. Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability fortreatment with the VDyne System.

Exclusion Criteria:

VDYNE SYSTEM SUITABILITY

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

2. Intolerance to procedural anticoagulation or post-proceduralantiplatelet/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

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

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

8. Right ventricular or atrial thrombus or vegetation

9. Severe tricuspid annular or leaflets calcification

10. Systolic pulmonary hypertension with systolic pulmonary artery pressure ≥70 mmHg. History of rheumatic fever CONCOMITANT PROCEDURES

11. Significant coronary artery disease requiring treatment such as symptomatic,unresolved multi-vessel or unprotected left main coronary artery disease.

12. Any planned surgery or interventional procedure within the period of 30 days priorto 30 days following the implant procedure. This includes any planned concomitantcardiovascular procedure such as CABG, PCI, pulmonary vein ablation, left atrialappendage occlusion, septal defect repair, etc

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

14. Cardiac resynchronization therapy device or implantable pulse generator implantedwithin 60 days of planned implant procedure.

15. Permanent pacing leads that will interfere with delivery or implantation of theVDyne Valve.

16. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanicalsupport devices at the time of planned implant procedure

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

18. Severe valvular heart disease requiring intervention other than the tricuspid valve

19. Known significant intracardiac shunt (e.g. septal defect) (PFO's without significantshunts are allowed) COMORBIDITIES

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

21. Severe lung disease (severe COPD or continuous use of home oxygen or oral steroids)

22. Acute myocardial infarction (AMI) within 30 days

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

24. End-stage liver disease (MELD > 11 / CHILD class C)

25. Bleeding requiring transfusion within 30 days

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

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

28. Any of the following: leukopenia, chronic anemia (Hgb < 9), thrombocytopenia,history of bleeding diathesis, or coagulopathy

29. Unwilling to receive blood products GENERAL EXCLUSION CRITERIA

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

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

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

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

34. Pregnant, lactating or planning pregnancy within next 12 months. (Female ofchild-bearing potential use two reliable contraceptive methods during the study -hormonal methods such as pill and condom).

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

36. Currently participating in an investigational drug or device trial that has notreached its primary endpoint or is likely to interfere with this study

37. Patient (or legal guardian) unable or unwilling to provide written informed consentbefore study-specific procedures are conducted

38. Patient unable or unwilling to comply with study required testing and follow-upvisits.

39. Rhuematic fever