Check a new heart valve treatment for older, high-risk patients
Part of Heart & circulation clinical trials.
This study follows how the VitaFlow heart valve works in people age 70+ who have severe, narrowed aortic valves and cannot safely get open-heart valve surgery. It’s meant to see whether the device improves outcomes and is safe over time.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are age 70 or older
- You have severe narrowing of the aortic valve with symptoms
- Your doctors say you are not a good candidate for surgical valve replacement
- Your heart and blood vessel shapes allow the valve to be placed through the usual access route
- You cannot have had a prior mechanical or tissue valve in the aortic position
- You can follow the required follow-up visits, and you have an expected lifespan of at least 12 months
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
Similar studies
Other trials that look related to this one.
This trial tests a new delivery system (VitaFlow Liberty Flex) for placing a replacement aortic valve in people with severe aortic stenosis. It is designed for patients whose heart anatomy (a steep angle between the heart and aorta) makes the procedure more challenging.
This trial studies Prizvalve Pro™, a new transcatheter (catheter-based) aortic valve replacement, for people with severe aortic valve narrowing who are too high-risk for standard surgery. It may help your heart work better and improve symptoms by replacing the failing valve without open-heart surgery.
This trial tests a new heart valve device (Venus-Vitae) for people with severe aortic stenosis, a condition where the heart valve is too tight. It aims to see if the device works well for patients of all surgical risk levels.
This trial tests a new valve replacement device (VitaFlow Liberty) that is inserted through a tube in an artery, avoiding open-heart surgery. It is for people with severe aortic stenosis who are at high risk for traditional surgery.
This study follows people who previously had the VitaFlow transcatheter aortic valve placed to learn how it does long-term. It may help doctors understand long-term safety and performance for this valve system.
This trial studies whether a new through-the-blood-vessel heart valve (TAVR) is safe and works well for people with severe aortic stenosis who are too risky for traditional surgery. If you qualify, you would be closely followed to check your symptoms and valve function over time.
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