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.
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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.
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This study tests a device called TriClip to repair a leaky tricuspid valve in the heart. If the leak is reduced, you may have less shortness of breath and feel more energetic.
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