New Heart Valve Device for Failed Surgical Aortic Valves
Part of Heart & circulation clinical trials.
This trial tests a newer self-expanding heart valve (Hydra) against a standard balloon-expandable valve in patients who need a replacement aortic valve because their previous surgical valve has failed. The goal is to see which approach works better and is safer for this situation.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are 18 years or older
- Your surgically implanted aortic valve has severely failed (not working properly) and your heart team agrees you need a replacement
- Your doctors agree you can have the valve placed through your groin artery (transfemoral access) and that both types of valves are suitable for you
- You are willing to sign a consent form and follow all study visits and exams for the required period
- You cannot be pregnant or nursing at the time of the procedure
- You do not have a recent heart attack, active infection, blood clots, severe kidney disease, or other conditions that would make the procedure too risky
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 heart valve called DurAVR for people with severe aortic stenosis (a narrowed aortic valve) who need a valve replacement. It compares the new valve to standard valves to see if it is safe and works well.
This trial tests a new heart valve called Hydra for people with severe aortic stenosis who need a valve replacement through a leg artery. It aims to see how well the valve works in real-world patients.
This study is testing a new heart valve system called Hydra, used during a less invasive procedure called TAVI to replace a narrowed heart valve. It may help people with severe aortic stenosis who are already candidates for TAVI.
This study tracks patients who receive a Hydra artificial heart valve to replace a severely narrowed aortic valve. Researchers will follow your progress to understand how well the device works and its safety in real-world use.
This trial studies whether the Myval THV (a new heart valve) is safe and effective for adults who need TAVI, a procedure to replace a narrowed heart valve without open-heart surgery. You may be considered if a heart team says you’re a good candidate for this valve procedure and you’re willing to join the study.
This trial tests a new, less invasive heart valve (called SAPIEN X4) placed through a vein in your leg to replace a failing mitral valve that was previously repaired or replaced. It is for people who are at high risk for open-heart surgery and have a leaky or narrowed mitral valve.
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