TRIcvalve BiCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)

Inclusion Criteria:

1. Subject must be 18 years or older, at the time of signing the informed consent.

2. Subjects has severe tricuspid regurgitation (TR), as determined by the qualifyingtransthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab.

3. NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admissionin the past 6 months.

4. Subject is adequately treated with optimal medical therapy (OMT) for heart failureper the local Heart Team for at least 30 days prior to the index procedure,including a diuretic.

5. The local Heart Team and IEC determine that the patient is eligible for theTricValve procedure.

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

7. Capable of giving signed informed consent.

Exclusion Criteria:

1. Subject had a recent MI, stroke or cardiovascular accident; underwent coronaryartery bypass graft surgery, had a percutaneous coronary intervention or other majorcardiovascular surgery within 90 days prior to TricValve implantation.

2. Subject requires another planned major cardiac procedure, including left-sidedtranscatheter intervention or surgery (e.g. severe aortic stenosis, severe mitralregurgitation), coronary artery bypass or PCI or pulmonary valve correction. Pleasenote that if closure of an ASD, iatrogenic ASD or PFO is performed, TricValveimplantation can be performed 30 days after the intervention. Additionally,TricValve implantation can be performed 30 days after any Electrophysiologyprocedure (pacemaker, ICD, etc.).

3. LVEF ≤ 30% on echocardiography.

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

5. Tricuspid stenosis. (Per TVARC, echo criteria: TVA at least 1.5 cm2 or TVAi at least 0.9 cm2/m2 [at least 0.75 if BMI >30 kg/m2], DVI <2.2, mean gradient <5mm Hg);reduction of total tricuspid regurgitation to optimal (≤ mild [1+]) or acceptable (≤moderate [2+]).

6. Severe right ventricular dysfunction.

7. Cardiac amyloidosis

8. Pulmonary artery systolic pressure (PASP) >65 mmHg assessed with Echo Doppler and /or right heart catheterization.

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 (i.e. leftventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heartfailure)

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. Any known life-threatening condition with an estimated life span of at least 12months.

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 requiring chronic renal replacement therapy at the time ofenrollment.

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 randomization.

23. Presence of significant congenital heart disease including but not limited tohemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenicRV.

24. Use or participation in other investigational device or drug study in which patienthas not reached a primary endpoint to treat cardiovascular conditions related to theoutcomes of the current 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 and those who plan pregnancy during the clinicalinvestigation follow-up period.