EXPLORE-MRace
EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)
AI Description
The goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation. It will also learn about the safety of the device MR-ace Implant and Delivery System. The main questions it aims to answer are:
Does implanting the MR-ace device reduce the symptoms of mitral regurgitation? Does the device reduce the the leak through your mitral valve?
Participants will:
Be implanted with the device Visit the clinic for checkups and tests at 30 days, 6 months, 12 months, and 2, 3, 4 and 5 years following your procedure Complete a quality of life survey
- Who can join
- adult, older adult
- Participants
- 15
- Expected completion
- 2032-12-31
- Funded by
- industry
Conditions studied
Mitral Regurgitation
What is being tested
- DEVICE: MR-ace Implant and Delivery System
What it measures
- Primary Performance Endpoint, Reduction in mitral regurgitation (Grade 2+ or less) as evaluated by 2D transthoracic echocardiography., 30 days post procedure
- Primary Safety Endpoint, All-cause mortality, 30 days post procedure
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2026-09-01
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.