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Study identifier: NCT07454980 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Tricuspid Regurgitation (TR)  ·  Sponsor: Jenscare Innovation Inc.

PhaseNA
Planned participants680
Who can joinAll sexes, 21 Years to no upper limit
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Chen Jiao, MD  ·  +86 13816576611  ·  jiaochen@jenscare.com

Always discuss trial participation with your own doctor first.

Locations (1)

Montefiore Medical CenterThe Bronx, New York, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07454980