Transcatheter mitral valve procedure for high-surgery-risk patients
Part of Heart & circulation clinical trials.
This trial studies a newer, catheter-based mitral valve treatment in people with moderate-severe to severe mitral valve leaking who are at high risk for open-heart surgery. It may help improve symptoms and heart function without traditional surgery, but you must meet key heart, anatomy, and safety requirements.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Be 18 years or older
- Have moderate-severe or severe mitral valve leakage (moderate-to-severe regurgitation)
- Have heart symptoms in NYHA class II, III, or “ambulatory” IV, and be on heart medicines for at least 1 month
- Be considered high-risk for open-heart surgery based on a Heart Team review (including health conditions, frailty, or disability)
- Have the right anatomy for the specific HighLife valve and be able to have a TEE scan (a heart ultrasound probe)
- Agree to the study plan, follow-up visits, and blood-thinner (anticoagulation) and/or anti-platelet medicines if needed
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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