TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)

Inclusion Criteria: * Age ≥18 years at time of consent * Severe or greater TR assessed on transthoracic echocardiography by Echocardiography Core Lab using a 5-grade classification (Mild, Moderate, Severe, Massive, Torrential). * New York Heart Association (NYHA) Class II-IV * The Patient is being treated on optimal dosage for diuretics at investigator discretion * The Site Heart Team concur the patient is not an optimal candidate for surgical treatment and it is anatomically suitable for transcatheter tricuspid valve replacement * Patient must be able to fully understand all aspects of the investigation that are relevant to the decision to participate and provide a written informed consent * Anatomical inclusion criteria confirmed by echocardiographic core lab, CT core lab and Eligibility Committee Exclusion Criteria: * Left Ventricular Ejection Fraction (LVEF) \<35% * Pulmonary arterial systolic pressure (PASP) \>60 mmHg by echo Doppler (unless right heart catheterization \[RHC\] demonstrates PASP ≤60mmHg); or Right 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. * Evidence of intracardiac mass, thrombus, or vegetation * Ebstein Anomaly or congenital right ventricular dysplasia * Surgical correction is indicated for other concomitant valvular disease (subjects with concomitant valvular disease may treat their respective valve first and wait 2 months be…