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

The Investigational Device is the TricValve Transcatheter Bicaval Valve System (also referred to as the TricValve System).

The bioprosthesis is available in two different diameters for each model (SVC and IVC) specifically designed to adapt to the anatomic features of the superior vena cava (SVC) and inferior vena cava (IVC).

The SVC and IVC valves are single use, sterile devices provided in two sizes each, for a total of four valve sizes. The valves are designed for heterotopic caval implantation without perturbing the native tricuspid valve. The valves are made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.

The SVC and IVC valves are provided pre-mounted in two separate TricValve Delivery Systems, and are individually packaged into two separate boxes, provided sterile and ready to use. The two TricValve Delivery Systems deliver the two valves percutaneously into the SVC and IVC via femoral vein access using a transvenous approach.

This is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the TricValve System with Optimal Medical Therapy (OMT) compared to OMT alone in the treatment of patients with severe TR and caval reflux (CR).

The TricValve System received Breakthrough Device Designation from the US FDA.

Eligibility Criteria:
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 the patient 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); major cardiovascular 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, thrombus or 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 time of 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 media that cannot be adequately treated with pre-medication.
13. Unable to tolerate anticoagulation/antiplatelet therapy.
14. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump 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) ≤ 25 mL/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 to hemodynamically 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 the opinion of the investigator.
26. Psychiatric/behavioral issues or other medical or social conditions that preclude valid consent and follow-up.
27. Pregnant or breastfeeding subjects.