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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Jenscare Innovation Inc.
Study ID
NCT07454980
Status
Recruiting
Apply to this trial

Conditions

  • Tricuspid Regurgitation (TR)

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Mar 6, 2026
Start date
Jul 15, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2038

Study Design

Enrollment
680 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Randomized cohort (EVOQUE Eligible Cohort): LuX-Valve
  • Active Comparator: Randomized cohort (EVOQUE Eligible Cohort): EVOQUE
  • Experimental: Single-arm cohort ("Not Suitable for Conventional TTVI"cohort): LuX-Valve

Primary Outcome Measure

Rate of Major Adverse Events (MAE) [ Time Frame: 30 Day Post-Procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10467
Edwin Ho, MD
[email protected]

Find similar trials in The Bronx, NY

By research site
Montefiore Medical Center· The Bronx, NY

Related Studies