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NCT06700239Possibly a fitNot yet recruiting

Tricuspid valve repair for leaky heart valve without open surgery

Tricuspid Regurgitation FunctionalTricuspid RegurgitationSevere Tricuspid Valve Regurgitation

Part of Heart & circulation clinical trials.

This study tests a new device to fix a leaking tricuspid valve (the valve that helps blood flow from the heart to the lungs) without open-heart surgery. It is for people with severe leaking that causes symptoms like shortness of breath or tiredness, and who are not good candidates for surgery.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
600 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have a severe leak in your tricuspid valve (the valve between the right heart chambers) that is not caused by a heart device like a pacemaker lead.
  • Your heart team has decided you are at medium or higher risk for surgery, and you have been on the best medical treatment (like water pills) for at least 30 days.
  • You have symptoms like tiredness or shortness of breath, but you can still do some daily activities (heart function class II, III, or IV, but not bedridden).
  • You do not have very high blood pressure in the lungs (pulmonary artery pressure less than 70 mmHg or 5 Wood units).
  • You have not had a previous repair or replacement of your tricuspid valve.
  • You do not have uncontrolled high blood pressure (systolic below 180 and diastolic below 100).
  • Your heart pumping function is at least 20% (LVEF ≥ 20%).

View the official record on ClinicalTrials.gov

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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