Mitral Valve Repair Using Polares System for Heart Failure
Part of Heart & circulation clinical trials.
This trial tests a minimally invasive procedure to repair a leaky mitral valve (the valve between the upper and lower chambers of your heart) in people with heart failure who haven't improved with medication alone. The procedure uses a catheter-based system inserted through the groin to replace part of the valve, potentially reducing symptoms and improving heart function.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Moderate-to-severe leaky mitral valve (grade 3+ or higher) confirmed by ultrasound within 60 days
- Heart failure symptoms (NYHA Class II, III, or ambulatory IV) despite maximum tolerated heart medications stable for 30 days
- Age 21 or older
- Deemed high-risk but operable for heart surgery (STS score less than 10%)
- Unsuitable for other catheter-based mitral valve treatments per your heart team
- Able to return for all follow-up visits and willing to participate
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 study is for people with severe mitral valve leakage (mitral regurgitation) who may need a valve replacement. It tests whether the ReValve system is safe and can help improve symptoms and heart function.
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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