Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)

Exclusion Criteria

• •1. Left ventricular ejection fraction (LVEF) \<35%.
• •2. Pulmonary arterial systolic pressure (PASP) \>60 mmHg by echo Doppler (unless right heart catheterization \[RHC\] demonstrates PASP ≤60mmHg); in case RHC is performed, PASP \>2/3 systemic BP with PVR \>5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP \<90 mmHg.
• •3. Evidence of intracardiac mass, thrombus, or vegetation.
• •4. Ebstein Anomaly or congenital right ventricular dysplasia.
• •5. Surgical or interventional correction is indicated for other concomitant valvular diseases (subjects with concomitant valvular disease may treat their respective valve first and wait 2 months before being reassessed for the trial).
• •6. Subjects with valve prostheses implanted in the tricuspid valve.
• •7. Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction.
• •8. Active infection, infective endocarditis or sepsis within 3 months, or infections requiring antibiotics treatment within two weeks prior to planned procedure.
• •9. Untreated clinically significant coronary artery disease requiring revascularization.
• •10. Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure.
• •11. Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure.
• •12. Cerebrovascular stroke (ischemic or bleeding) within 3 months prior to enrollment.
• •13. Active peptic ulcer or active gastrointestinal bleeding within 3 months prior to enrollment.
• •14. Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis, or coagulopathy.
• •15. Inability to tolerate anticoagulation or antiplatelet therapy.
• •16. Renal insufficiency (eGFR\< 30ml/min \[per the CKD-EPI formula\] and/or renal replacement therapy).
• •17. Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C
• •18. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements.
• •19. Severe Chronic Obstructive Pulmonary Disease requiring steroids or requiring continuous home oxygen.
• •20. Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media.
• •21. Estimated life expectancy \<12 months.
• •22. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
• •23. Subjects with current history of illicit drug use.
• •24. Any other condition making it unlikely the patient will be able to complete all protocol procedure and follow-ups determined by the investigator.