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

Inclusion Criteria:

1. Age≥50 years at time of consent

2. Severe or greater TR (≥3+) assessed on transthoracic echocardiography by Echo CoreLab (ECL) using a 5-grade classification

3. New York Heart Association (NYHA) Class II-IV

4. In the judgment of the Site Heart Team, the subject has been adequately treated perapplicable standards, including optimal medical therapy with diuretics

5. The Site Heart Team concur the benefit-risk analysis supports transcathetertricuspid valve replacement per current guidelines for the management of valvularheart disease, and the subject is at high risk for tricuspid valve surgery.

6. Patient must be able to fully understand all aspects of the investigation that arerelevant to the decision to participate, and provide a written informed consent

7. In France, patient is affiliated to a health social security regimen or equivalent

Exclusion Criteria:

1. Pulmonary arterial systolic pressure (PASP) > 60 mmHg by echo Doppler (unless rightheart catheterization [RHC] demonstrates PASP ≤60 mmHg) or R heart catheterizationOR PASP > 2/3 systemic BP with PVR > 5 Wood units after vasodilator challenge, inthe 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) Subjectswith concomitant valvular disease may treat their respective valve first, and wait 2months 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 clinicallysignificant prosthetic dysfunction

9. Sepsis or active endocarditis within 3 months, or infections requiring antibiotictherapy 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 priorto the planned procedure

12. Any percutaneous coronary, intracardiac or carotid intervention within 30 days priorto 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 monthsto enrollment

15. Inability to tolerate anticoagulation or antiplatelet therapy

16. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, ormechanical hemodynamic support

17. Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renalreplacement 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 thelocal 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 investigationaldrug or device that has not yet completed its primary endpoint.

22. Pregnant or lactating; or female of childbearing potential with a positive pregnancytest within 14 days prior to intervention (contraceptive requirement is shown inAppendix XI)

23. Allergic to one or more of the substances contained in the implant and/or deliverysystem, including nitinol, tantalum, PET, PTFE, bovine pericardium, Pebax, PA,Polyurethane, Stainless steel.