The goal of this clinical trial is to learn if LuX-Valve Plus system works to treat symptomatic subjects with at least severe tricuspid regurgitation (TR). It will also learn about the safety of LuX-Valve Plus system.
Researchers will compare LuX-Valve Plus system to a conventional device called EVOQUE to see if LuX-Valve Plus system works to treat subjects with at least severe tricuspid regurgitation.
Participants will:
Undergo one procedure using the LuX-Valve Plus system or EVOQUE after passing screening and enrolling in the trial; Complete follow-up visits and examinations as required by the trial protocol; Report any adverse events
Subject is at least 21 years of age at time of consent.
Subject (or legal guardian) understands trial requirements and treatment procedures and is able to provide written informed consent.
Severe or greater TR as assessed on transthoracic echocardiography by core lab.
New York Heart Association (NYHA) Class II-IV.
Left ventricular ejection fraction (LVEF) <35%.
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.
Evidence of intracardiac mass, thrombus, or vegetation.
Ebstein Anomaly or congenital right ventricular dysplasia.