Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)

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

NCT Number	NCT07454980
Lead Sponsor	Jenscare Innovation Inc.
Conditions	Tricuspid Regurgitation (TR)
Enrollment	680 participants
Start Date	2026-07-15
Primary Completion	2029-12 (estimated)
Study Completion	2038-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-29