TRICAV-II Pivotal: TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation.

Inclusion Criteria:

1. The subject must be 18 years or older.

2. Severe tricuspid regurgitation (TR), as determined by Echo Core Lab.

3. NYHA Class III-IVa or heart failure (HF) admission in the past 6 months.

4. Subject is treated with stable OMT for at least 30 days.

5. The local Heart Team and Independent Eligibility Committee (IEC) determine that thepatient is eligible

6. For females of childbearing potential, negative pregnancy test.

7. Capable and willing to provide signed informed consent.

Exclusion Criteria:

1. Recent Myocardial Infarction (MI), stroke or Cerebrovascular Accident (CVA); majorcardiovascular surgery within 90 days.

2. Subject requires another planned major cardiac procedure.

3. Left Ventricular Ejection Fraction (LVEF) ≤ 30% on echocardiography.

4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombusor vegetation.

5. Tricuspid stenosis.

6. Severe right ventricular dysfunction.

7. Cardiac amyloidosis.

8. Pulmonary artery systolic pressure (PASP) >65 mmHg.

9. Lower extremity venous thrombosis and/or the presence of an IVC filter at the timeof or 6 months prior to TricValve procedure.

10. Hemodynamically significant pericardial effusion.

11. Patient with refractory heart failure requiring advanced intervention

12. Any known allergy or hypersensitivity to nitinol, bovine tissue or contrast mediathat cannot be adequately treated with pre-medication.

13. Unable to tolerate anticoagulation/antiplatelet therapy.

14. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloonpump or acute heart failure within 30 days prior to the TricValve procedure.

15. Life expectancy lower than 12 months.

16. Platelet count < 75,000/mm3.

17. Child-Pugh Severity Class C (10-15 points).

18. Severe renal insufficiency with Estimated Glomerular Filtration Rate (eGFR) ≤ 25mL/min/1.73 m2 or dialysis.

19. Endocarditis or active/ongoing infection requiring antibiotics.

20. Unable to walk at least 60 meters in a 6minute walk test.

21. Known bleeding or clotting disorders or patient refuses blood transfusion.

22. Active gastrointestinal (GI) bleeding within 3 months of TricValve procedure.

23. Presence of significant congenital heart disease including but not limited tohemodynamically significant atrial septal defect, Right ventricular (RV) dysplasia,and arrhythmogenic RV.

24. Participation in other investigational devices or drug study.

25. Any other condition that would preclude ability to meet study requirements in theopinion of the investigator.

26. Psychiatric/behavioral issues or other medical or social conditions that precludevalid consent and follow-up.

27. Pregnant or breastfeeding subjects.