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
NCT07454980
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Montefiore Medical Center
The Bronx, New Yorkstudy coordinator listed
Recruiting
Montreal Heart Institute
Montreal, Quebec, Canadastudy coordinator listed
Recruiting
NCH Rooney Heart Institute (NAPLES COMPREHENSIVE HEALTH)
Naples, Floridastudy coordinator listed
Recruiting
Ottawa Heart Institute Research Corporation
Ottawa, Ontario, Canadastudy coordinator listed
Recruiting
Santé Québec - Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, Canadastudy coordinator listed
Recruiting
St. Michael's Hospital
Toronto, Ontario, Canadastudy coordinator listed
Recruiting
St. Paul's Hospital
Vancouver, British Columbia, Canadastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Rate of Major Adverse Events (MAE)30 Day Post-Procedure
Rate of Major Adverse Events (MAE) 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
- Rate of Composite Clinical Success12 Months Post-Procedure
Percentage (%) of participants achieving composite clinical success at 12 months. Composite clinical success is defined as meeting all of the following criteria: Patient survival, Free from heart failure hospitalization, No tricuspid valve surgery or percutaneous intervention