TRANSOM
Transventricular Off-pump Mitral Valve Repair
AI Description
The purpose of this study is to assess the safety and effectiveness (usefulness) of an investigational technique used to repair the mitral valve for patients with mitral regurgitation due to a defective valve leaflet. This procedure is called trans-ventricular off-pump mitral valve repair (TRANSOM) and it repairs the mitral valve by replacing some of the cords that support the mitral valve. This type of repair is minimally-invasive since it is performed through a small incision and avoids making a breast-bone-splitting incision.
- Who can join
- adult, older adult
- Participants
- 175
- Expected completion
- 2029-07-01
- Funded by
- other
Conditions studied
Mitral Valve (MV) Regurgitation
What is being tested
- DEVICE: TRANSOM
What it measures
- Primary Effectiveness Endpoint: Composite Freedom from Death, Recurrent mitral regurgitation (MR), and Re-intervention, Freedom from all-cause mortality, recurrent moderate or severe mitral regurgitation, and re-intervention on the mitral valve., 1 year post-index procedure.
- Primary Safety Endpoint: Composite Freedom from Major Adverse Events, Freedom from a composite of major adverse events including all-cause mortality, all stroke, acute kidney injury (AKI), major bleeding, new permanent pacemaker implantation, deep sternal wound infection (DSWI) or access site infection requiring surgical intervention, and prolonged mechanical ventilation., 30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2026-07-24
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.