Testing a new catheter procedure to replace a leaking mitral valve
Part of Heart & circulation clinical trials.
This trial studies whether a new catheter-based system can replace a badly leaking mitral valve in people who have symptoms. It may help if you can’t safely get current approved valve treatments or standard surgery.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You have moderate-to-severe or severe mitral valve leakage causing symptoms
- Your heart team decides you are not suitable for approved catheter repair or usual mitral valve procedures
- You have not had a previous mitral valve replacement or repair using a catheter device that is still in place
- Your heart’s pumping strength (left ventricular ejection fraction) is at least 25%
- Your heart valve/heart structure has no major anatomic problems that block the procedure
- You are not too unstable and do not need urgent or emergency surgery
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 trial studies a new way to replace a damaged mitral heart valve using a catheter (a thin tube), instead of open-heart surgery. It may help people who have severe leaking of the mitral valve but are considered too high-risk for surgery.
This trial studies a catheter-based procedure to replace the mitral valve in people with severe (or specific moderate) mitral valve leakage that causes symptoms. It may help by reducing leaking and related symptoms when standard surgery or less invasive fixes aren’t suitable for you.
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This study looks at how safe and effective a specific catheter procedure is for people with moderate-to-severe mitral valve leakage. It may help those who are considered high risk for traditional open-heart surgery.
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.
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