Study of a new heart valve for severe aortic stenosis
Part of Heart & circulation clinical trials.
This trial tests a new version of a heart valve (SAPIEN X4) placed without open-heart surgery. It's for people with severe aortic stenosis who have symptoms like shortness of breath or chest pain.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You have severe narrowing of your aortic heart valve (aortic stenosis) that is caused by calcium buildup.
- Your aortic valve opening is the right size for the new valve.
- You have symptoms like fatigue, shortness of breath, or chest pain (NYHA class II or higher).
- You are able to have the valve placed through a blood vessel in your leg.
- You have not had a heart valve replacement before and do not need another heart valve repair soon.
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 studies a new “valve-in-valve” procedure to treat a failing aortic bioprosthetic valve. It may help people improve blood flow through the heart valve and reduce valve-related problems.
This trial studies whether a new transcatheter aortic valve (SAPIEN X4) is safe and works well in people whose previously implanted aortic valve is now failing. It may help reduce valve symptoms in higher-surgery-risk patients who are not good candidates for open-heart valve replacement.
This trial tests a new, less invasive replacement valve for people whose mitral heart valve is failing. The goal is to improve blood flow and reduce symptoms like shortness of breath without the need for major open-heart surgery.
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.
This trial tests a new valve device placed through a small tube (catheter) to treat severe aortic stenosis, a condition where the aortic valve is narrowed and doesn't open fully. It's for patients who cannot have traditional open-heart surgery.
This study follows patients with severe aortic stenosis who get a new heart valve (the SAPIEN 3 Ultra RESILIA) through a less invasive procedure (TAVR). Researchers want to see how well this valve works over time using special heart ultrasound tests.
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