Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

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

Participants needed: 680
Trial details
Age: 21+Biological sex: AllType: InterventionalSponsor: Jenscare Innovation Inc.Updated: Mar 6, 2026
Eligibility criteria

Subject is at least 21 years of age at time of consent. [+9]

Left ventricular ejection fraction (LVEF) <35%. [+23]