Pivotal TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With Lux Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation - Clinical SafetY and Effectiveness
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
⁃ For the randomized study:
• 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.
• On optimal medical therapy (OMT) for TR at the time of baseline assessment per site Heart Team. OMT includes stable oral diuretic medications unless patient has a documented history of intolerance.
• The site Heart Team concurs that the patient is a good candidate for transcatheter tricuspid valve replacement and suitable for LuX-Valve Plus system by core lab.
• The commercial sponsor for EVOQUE deems that the patient is a good candidate for EVOQUE valve (control arm).
⁃ For single arm cohort (Not Suitable for Conventional TTVI)
• Meets all criteria 1-6 above
• The EVOQUE commercial sponsor deems the anatomy unsuitable for EVOQUE tricuspid valve replacement, or the annular perimeter is smaller or greaterthan EVOQUE commercial Instructions for Use (IFU), as determined by the clinical site
• Two independent Structural Cardiologists determine the patient Not Suitable for Transcatheter edge to edge repair