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

NCT07454980 NA NOT_YET_RECRUITING

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

Details

Lead sponsor	Jenscare Innovation Inc.
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	680
Start date	2026-05
Completion	2038-12

Conditions

• Tricuspid Regurgitation (TR)

Interventions

• TTVI with LuX-Valve Plus System
• TTVI with EVOQUE

Primary outcomes

• Rate of Major Adverse Events (MAE) — 30 Day Post-Procedure
  Rate of Major Adverse Events (MAE) in experimental arm (LuX-Valve \& EVOQUE) at 30 days consisting of the following components: * Cardiovascular Mortality * Myocardial Infarction (MI), periprocedural and spontaneous * All Stroke, disabling and non-disabling * New need for renal replacement therapy * Severe bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\] * Non-elective tricuspid valve re-intervention, surgery or transcatheter * Major access site and vascular complications * Major cardiac structural complications * Device-related pulmonary embolism * Arrhythmia and conduction disorders requiring permanent pacing
• Hierarchical composite endpoint: All-cause mortality, Heart failure hospitalization, and Tricuspid valve surgery or percutaneous intervention — 12 Months Post-Procedure
  Comparison of number of wins with composite endpoint events or improvement between experimental and active comparator arms