Repairing leaky mitral valve when standard clips are not an option
Part of Digestive system, Heart & circulation clinical trials.
This study tests a new device called MRace that is placed through a vein in the leg to fix a leaky mitral valve (the valve between the upper and lower left heart chambers). It is for people who have significant leakage and whose heart anatomy does not allow the usual clip repair. The goal is to see if the MRace can safely and effectively reduce the leak and improve symptoms.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You have symptoms like shortness of breath, fatigue, or swelling despite taking heart medications for at least 30 days.
- Your mitral valve leak is moderate-to-severe or severe (grade 3+).
- You have heart failure symptoms (NYHA class II, III, or IV, but not class IV if you are bedridden).
- Your risk for heart surgery is high but not too high (a score under 10%).
- Your heart structure is not suitable for the standard clip procedure (M-TEER), but your valve is compatible with the MRace device.
- You are 21 years or older and able to attend follow-up visits for the study.
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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