Clips for leaky mitral valve in high-surgery-risk heart patients
Part of Heart & circulation clinical trials.
This trial studies whether a device called GeminiOne can safely and effectively repair a leaky mitral valve using a catheter-based “clip” technique. It may help patients who have moderate-to-severe or severe valve leakage but are considered too high-risk for open surgery.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be 18 or older and willing to sign consent and follow the study plan.
- Your echocardiogram tests (ultrasound of the heart) must be recent: one transthoracic within 90 days and one transesophageal within 180 days.
- Your mitral valve leak must be moderate-severe or severe, causing symptoms (NYHA II, III, or non-walking NYHA IV).
- Your pumping strength (LVEF) must be at least 20%.
- A heart team must say you are high risk for mitral valve surgery and that your heart anatomy fits the device.
- Your groin vein and the ultrasound-guided procedure access must be possible for the catheter and clip placement.
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 GeminiOne that clips together part of your leaky mitral valve to reduce backward blood flow. It is for people with severe mitral regurgitation who are not candidates for open-heart surgery.
This trial tests Valveclip, a catheter-based way to repair a mitral valve that is leaking badly. It may help people who are high-risk for open surgery by aiming to reduce the leak with a less invasive approach.
This trial tests a clip-based procedure (TEER) to fix a severe leak in the mitral valve for people who have symptoms or heart changes but are at low to medium risk for surgery. The goal is to see if this less invasive option works well and is safe.
This trial studies a minimally invasive device meant to fix a badly leaking mitral valve (mitral regurgitation) without open-heart surgery. It may be an option if you’re considered too high-risk for standard surgery and your heart anatomy fits the device.
This study tests a new clip procedure (CardioClip) to repair a leaky mitral valve in people with heart failure. It aims to see if the clip can improve symptoms and heart function.
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.
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