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

Eligibility 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 qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab.
• 3. NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
• 4. Subject is adequately treated with optimal medical therapy (OMT) for heart failure per 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 the TricValve procedure.
• 6. For females of childbearing potential, negative pregnancy test.
• 7. Capable of giving signed informed consent.
• 1. Subject had a recent MI, stroke or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention or other major cardiovascular surgery within 90 days prior to TricValve implantation.
• 2. Subject requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis, severe mitral regurgitation), coronary artery bypass or PCI or pulmonary valve correction.
• 3. LVEF ≤ 30% on echocardiography.
• 4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or 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 time of or 6 months prior to TricValve procedure.
• 10. Hemodynamically significant pericardial effusion.
• 11. Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heart failure)
• 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. Any known life-threatening condition with an estimated life span of at least 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 requiring chronic renal replacement therapy at the time of enrollment.
• 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 to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
• 24. Use or participation in other investigational device or drug study in which patient has not reached a primary endpoint to treat cardiovascular conditions related to the outcomes of the current 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 and those who plan pregnancy during the clinical investigation follow-up period.