Comparing two new heart valve replacement devices
Part of Heart & circulation clinical trials.
This trial compares two newer types of replacement heart valves (SAPIEN 3 Ultra Resilia and Evolut FX) to see which one works better for people with severe aortic stenosis, a condition where the heart's main valve becomes narrow. If you join, you'll be randomly assigned to receive one of the two valves during your TAVI procedure.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You have severe aortic stenosis, meaning your aortic valve opening is small (< 1.0 cm²) or your pressure gradient is high, as measured by an echo.
- You have symptoms like shortness of breath, chest pain, or fatigue (NYHA class II, III, or IV).
- Your heart team has decided that TAVI (a procedure to replace the valve without open-heart surgery) is right for you.
- Your CT scan shows you are suitable for both valve types being tested.
- You are 18 years or older and can give informed consent.
- You have not had a prior surgical or TAVI valve replacement, and you do not have severe leakage in other heart valves that needs treatment.
- You do not have a bicuspid valve (a heart valve with two flaps instead of three) and are not pregnant or breastfeeding.
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 compares two different types of replacement heart valves (balloon-expandable vs. self-expanding) to see which works better for people with severe aortic stenosis. The goal is to find the best option for each patient.
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