Cephea valve study for severe mitral valve disease
Part of Heart & circulation clinical trials.
This study tests a new device called the Cephea valve, which is placed through a small tube (catheter) to treat severe leaking or narrowing of the mitral valve. It may be an option for people who are not good candidates for open-heart surgery.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You have severe mitral regurgitation (leaking) or severe mitral stenosis (narrowing) of the heart's mitral valve.
- Your heart's pumping function is at least 30% (measured by an ejection fraction test).
- Your heart team believes that a catheter-based treatment is safer or more appropriate for you than open-heart surgery.
- You have not had prior heart procedures that would interfere with placing this new valve.
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 study tests a new device that replaces a leaking mitral valve without open-heart surgery. It may help people who have severe mitral valve leakage but cannot safely have standard surgery or some other less invasive valve repairs.
This study tracks people with mitral valve disease who receive the Cephea valve through a tube in an artery rather than open-heart surgery. It looks at how well the valve works over time.
This study tests a new catheter-based system to treat severe mitral valve leaking when open-heart surgery is considered high risk. It may help improve blood flow and symptoms by repairing the valve without open surgery, using ultrasound guidance and follow-up visits to track safety and results.
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This trial tests a new way to replace the mitral valve using a soft tube (catheter) inserted through the leg, for people with severe leaky mitral valve who are not candidates for traditional surgery or clip repair. It aims to see how well this valve works in real-world patients across Europe.
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