A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement

Exclusion Criteria

• •1. Pulmonary arterial systolic pressure (PASP) \> 60 mmHg by echo Doppler (unless right heart catheterization \[RHC\] demonstrates PASP ≤60 mmHg) or R heart catheterization OR PASP \> 2/3 systemic BP with PVR \> 5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP \< 90 mmHg.
• •2. Left Ventricular Ejection Fraction (LVEF) \<35%
• •3. Evidence of intracardiac mass, thrombus or vegetation
• •4. Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
• •5. Ebstein Anomaly or congenital right ventricular dysplasia
• •6. Surgical correction is indicated for other concomitant valvular disease (e.g., severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation) Subjects with concomitant valvular disease may treat their respective valve first, and wait 2 months before being reassessed for the trial.
• •7. Patients with valve prostheses implanted in the tricuspid valve
• •8. Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction
• •9. Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure
• •10. Untreated clinically significant coronary artery disease requiring revascularization
• •11. Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure
• •12. Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure
• •13. Cerebrovascular stroke (ischemic or bleeding) within prior 3 months to enrollment
• •14. Active peptic ulcer or active gastrointestinal (GI) bleeding within prior 3 months to enrollment
• •15. Inability to tolerate anticoagulation or antiplatelet therapy
• •16. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
• •17. Renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy at the time of screening
• •18. Chronic liver failure or cirrhosis with MELD-Albumin Score ≥ 12
• •19. Severe lung disease or patient dependent on home oxygen and deemed unsuitable by the local heart team or eligibility committee for the study.
• •20. Futility with estimated life expectancy\<12 months.
• •21. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
• •22. Pregnant or lactating; or female of childbearing potential with a positive pregnancy test within 14 days prior to intervention (contraceptive requirement is shown in Appendix XI)
• •23. Allergic to one or more of the substances contained in the implant and/or delivery system, including nitinol, tantalum, PET, PTFE, bovine pericardium, Pebax, PA, Polyurethane, Stainless steel.