TRINITY Pivotal Trial for Tricuspid Regurgitation
This study is testing two devices, the LuX-Valve Plus System and EVOQUE, for people with severe tricuspid regurgitation (TR), a condition where a heart valve doesn't close properly. Researchers want to see if the LuX-Valve Plus System is safe and effective compared to EVOQUE. They will look at serious problems that might happen after the procedure and how well people are doing after one year, including hospitalizations and the need for more heart procedures. You may be able to join if you are at least 21 years old, have severe TR, and experience symptoms like shortness of breath or fatigue (NYHA Class II-IV). The study aims to enroll 680 participants.
- Study design
- This interventional study is comparing two devices, the LuX-Valve Plus System and EVOQUE, in 680 participants. The phase of the study is not specified.
- What's involved
- You would undergo one procedure using either the LuX-Valve Plus System or EVOQUE, complete follow-up visits and examinations, and report any side effects.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 12 months after the procedure to assess their health and any further interventions.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Rate of Major Adverse Events (MAE)30 Day Post-Procedure
Rate of Major Adverse Events (MAE) in experimental arm (LuX-Valve \& EVOQUE) at 30 days consisting of the following components: * Cardiovascular Mortality * Myocardial Infarction (MI), periprocedural and spontaneous * All Stroke, disabling and non-disabling * New need for renal replacement therapy * Severe bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\] * Non-elective tricuspid valve re-intervention, surgery or transcatheter * Major access site and vascular complications * Major cardiac structural complications * Device-related pulmonary embolism * Arrhythmia and conduction disorders requiring permanent pacing
- Hierarchical composite endpoint: All-cause mortality, Heart failure hospitalization, and Tricuspid valve surgery or percutaneous intervention12 Months Post-Procedure
Comparison of number of wins with composite endpoint events or improvement between experimental and active comparator arms