A new device for mitral regurgitation when standard repair is 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 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.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You have moderate-to-severe or severe mitral regurgitation (a leaky heart valve) that causes symptoms despite taking the right heart medications.
- You are 21 years of age or older and are considered high risk for open-heart valve surgery by your heart team.
- Your heart team has found that the standard clip repair (M-TEER) would not work because of your specific valve shape or size.
- At least one of several unusual valve features must be present, such as a very short or thick leaflet, heavy calcium, or a large gap between leaflets.
- You must be able to come back for follow-up visits and give written consent to participate.
- You do not have certain severe conditions, such as a very weak heart pump (ejection fraction under 30%), severe lung or kidney disease, or a recent stroke or heart attack.
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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