Early study of the Pivot Extend system for leaky tricuspid valve
Part of Heart & circulation clinical trials.
This trial tests a new device (Pivot Extend) to fix a severe leak in your tricuspid heart valve. It is for people who still have symptoms like shortness of breath or fatigue despite taking medicine.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be 18 or older and have signed a consent form.
- You have severe (3+ out of 4) tricuspid valve leakage on an echo.
- Your symptoms (like trouble breathing or tiredness) are at least class II despite using optimal medicines for 30 days.
- A heart team (cardiologist and surgeon) must agree this procedure is right for you.
- You cannot have certain heart devices (like a pacemaker), blood clots, bleeding problems, or other serious conditions.
- You must be able to follow instructions and commit to the whole study.
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 procedure that uses a small clip to fix a leaky tricuspid valve in the heart. The goal is to reduce symptoms like shortness of breath and fatigue, and help you feel better in your daily life.
This trial tests a catheter-based procedure (done through the blood vessels) to repair a severely leaky tricuspid valve. It may help people with symptoms or past hospitalizations from tricuspid valve leakage who are higher-risk for standard surgery.
This trial tests a new device called Laplace TTVR to replace a leaky tricuspid valve in the heart without open surgery. It is for people with severe symptoms despite medical treatment.
This trial tests a new catheter-based device to replace your tricuspid valve without open-heart surgery. It's for people with severe tricuspid regurgitation who are at high risk for surgery.
This study tests a new catheter-based device to repair a leaky tricuspid heart valve (tricuspid regurgitation) in people who still have symptoms like shortness of breath or swelling despite taking heart medications. The goal is to see if the procedure is safe and can help reduce the leak.
This study tests a clip device to fix a leaky tricuspid valve without open-heart surgery. It may help people who have symptoms like breathlessness or swelling and are not good candidates for surgery.
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