New device for severe leaky heart valve when surgery is not possible
Part of Digestive system clinical trials.
This trial is testing a new device to help people with severe mitral regurgitation (a leaky heart valve) who cannot have open-heart surgery or a valve clip. The device is placed using a thin tube through a blood vessel, and aims to improve symptoms and quality of life.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You have severe mitral regurgitation (a leaky heart valve) that causes symptoms like shortness of breath or fatigue.
- Your heart team has decided that open-heart surgery is not safe or appropriate for you.
- A less invasive clip procedure (transcatheter edge-to-edge repair) is not possible because of the shape of your valve.
- You have been on stable heart failure medications for at least one month, and if you have a special pacemaker, it has been in place for at least 3 months.
- You have not had a stroke or mini-stroke in the last 30 days, and you have no history of bleeding problems.
- You are able to take blood thinners (like warfarin, aspirin, or clopidogrel) for at least 6 months after the procedure.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
Similar studies
Other trials that look related to this one.
This trial tests a new device, called MRace, that is placed with a thin tube into the heart to fix a leaky mitral valve. It's for people whose valve is too complex for the usual clip repair, and who are too high-risk for open-heart surgery.
This study tests a new device called MRace for people with a leaking mitral valve (functional mitral regurgitation) whose heart structure makes standard repair difficult. The device is placed through a vein in the leg to fix the leak without open-heart surgery.
This trial tests a new device that is placed using a thin tube through a vein in the leg to repair a leaky mitral valve in people with heart failure. The goal is to see if it can reduce symptoms and improve quality of life beyond what usual medications can do.
This study tests a new device that replaces a leaking mitral valve without open-heart surgery. It may help people who have severe mitral valve leakage but cannot safely have standard surgery or some other less invasive valve repairs.
This trial tests a new device called the Capstan system to fix a leaky mitral valve (mitral regurgitation) without open-heart surgery. It may help people whose valve leak is moderate to severe and still have symptoms despite medicines.
This trial tests a new device to fix a leaky mitral valve in people with moderate to severe leakage who are too high-risk for open-heart surgery. It aims to improve heart function and symptoms.
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