Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The… (NCT07454980) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)
680 participantsStarted 2026-05
Plain-language 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
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Subject is at least 21 years of age at time of consent.
✓. Subject (or legal guardian) understands trial requirements and treatment procedures and is able to provide written informed consent.
✓. Severe or greater TR as assessed on transthoracic echocardiography by core lab.
✓. New York Heart Association (NYHA) Class II-IV.
✓. On optimal medical therapy (OMT) for TR at the time of baseline assessment per site Heart Team. OMT includes stable oral diuretic medications unless patient has a documented history of intolerance.
✓. The site Heart Team concurs that the patient is a good candidate for transcatheter tricuspid valve replacement and suitable for LuX-Valve Plus system by core lab.
✓. The commercial sponsor for EVOQUE deems that the patient is a good candidate for EVOQUE valve (control arm).
✓. Meets all criteria 1-6 above
Exclusion criteria
✕
What they're measuring
1
Rate of Major Adverse Events (MAE)
Timeframe: 30 Day Post-Procedure
2
Hierarchical composite endpoint: All-cause mortality, Heart failure hospitalization, and Tricuspid valve surgery or percutaneous intervention
. Left ventricular ejection fraction (LVEF) \<35%.
✕. Pulmonary arterial systolic pressure (PASP) \>60 mmHg by echo Doppler (unless right heart catheterization \[RHC\] demonstrates PASP ≤60mmHg); in case RHC is performed, PASP \>2/3 systemic BP with PVR \>5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP \<90 mmHg.
✕. Evidence of intracardiac mass, thrombus, or vegetation.
✕. Ebstein Anomaly or congenital right ventricular dysplasia.
✕. Surgical or interventional correction is indicated for other concomitant valvular diseases (subjects with concomitant valvular disease may treat their respective valve first and wait 2 months before being reassessed for the trial).
✕. Subjects with valve prostheses implanted in the tricuspid valve.
✕. Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction.
✕. Active infection, infective endocarditis or sepsis within 3 months, or infections requiring antibiotics treatment within two weeks prior to planned procedure.