Mitral valve clip repair for leak caused by heart failure
Part of Heart & circulation clinical trials.
This study tests a minimally invasive procedure using a clip to fix a leaky mitral valve caused by an enlarged heart (atrial functional mitral regurgitation) in people with heart failure who are not good candidates for open-heart surgery. The clip helps the valve close better, which may reduce symptoms and improve quality of life.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are 18 years or older.
- You have symptoms of heart failure (like shortness of breath or fatigue) and are in NYHA class II, III, or IV (able to be up and about, but limited).
- Echocardiography shows moderate-to-severe leakage (3+ or 4+) of the mitral valve due to an enlarged left atrium, not due to a damaged valve.
- You have been hospitalized for heart failure in the last year or have high levels of BNP or NT-proBNP (heart failure markers).
- You have been on optimal heart failure medications for at least 3 months, and other heart conditions (like atrial fibrillation) have been treated appropriately.
- A heart team has decided that open-heart surgery is too risky or not the best option for you.
- Your heart's structure is suitable for the clip procedure, as confirmed by imaging.
- You are willing to possibly be assigned to the medication-only group (without the clip) if randomized.
- You do not have any of the excluded conditions (like severe other valve disease, recent stroke, or severe lung disease).
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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