TAVR for bicuspid aortic valve with a specific device
Part of Heart & circulation clinical trials.
This study tests a “solution” approach using a self-expanding valve during TAVR (a less invasive way to replace a narrowed aortic valve). It aims to improve how well the valve fits and works in people with a specific heart valve shape (bicuspid aortic stenosis).
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are getting TAVR through the thigh blood vessels (transfemoral approach).
- You have severe bicuspid aortic valve narrowing (aortic stenosis) with test-confirmed measurements.
- You are at least 65, or 60–64 with high surgical risk based on risk and health-function assessments.
- Your heartbeat symptoms are at least moderate (NYHA class II or higher).
- CT scan shows the valve shape is Sievers type 0 or type 1, and the valve opening size fits the study range.
- You must not have major problems that make valve placement unsafe (example: certain vessel/tortuous anatomy or high risk for complications by CT review).
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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