Study of a new device for severe mitral regurgitation
Part of Digestive system clinical trials.
This trial tests a new device called HighLife Clarity for people with severe leakage of the mitral valve (a heart valve). It aims to see if the device can help patients who cannot have standard surgery or other minimally invasive treatments.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be at least 18 years old (or the legal age in your country).
- You have moderate-to-severe or severe mitral regurgitation (leaky valve) caused by heart muscle problems or the valve ring being too wide.
- Your heart team has decided that standard heart surgery is not right for you, and you are not suitable for another minimally invasive procedure called TEER.
- You are on the best medical therapy for your heart failure for at least one month, and if you have a pacemaker for heart failure, it has been in place for at least 3 months.
- You have symptoms like shortness of breath or fatigue (classified as NYHA class II, III, or IV).
- You are willing to take blood-thinning medication (anticoagulants) for at least 6 months after the procedure.
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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