NCT07454980

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 680 (estimated)
• Sponsor: Jenscare Innovation Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Tricuspid Regurgitation (TR)

Interventions

Type	Name	Description
DEVICE	TTVI with LuX-Valve Plus System	Transvenous tricuspid valve replacement with Lux-Valve Plus System in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)
DEVICE	TTVI with EVOQUE	Transvenous tricuspid valve replacement with EVOQUE in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-12-01
• Completion: 2038-12-01
• First posted: 2026-03-06
• Last updated: 2026-03-06

Regulatory

• FDA-regulated device study