Mitral valve repair for leak with complex anatomy
Part of Digestive system, Heart & circulation clinical trials.
This study tests a new device, MRace, for people with severe functional mitral regurgitation, a condition where the heart's mitral valve doesn't close fully, causing blood to leak backward. The trial is for patients who have unusual heart structures that make the standard clip procedure difficult. The goal is to see if MRace can safely and effectively fix the leak and improve symptoms.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Have symptoms like shortness of breath or fatigue despite taking heart medications
- Have moderate-to-severe or severe mitral valve leakage as measured by an echo (heart ultrasound)
- Be in heart failure classes II, III, or ambulatory IV, meaning you can still walk around but may get tired easily
- Be at high risk for heart surgery but stable enough to be considered operable
- Have heart anatomy that is not suitable for the standard clip procedure (M-TEER)
- Be 21 years or older and able to attend follow-up visits
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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This study tests a new device called MRace that is placed through a vein in the leg to fix a leaky mitral valve in people whose valve shape is not suitable for the usual repair. It is for patients with heart failure and moderate-to-severe regurgitation who are still able to have surgery but are considered high risk.
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