Mi-thos® Transcatheter Mitral Valve Replacement Study

This study evaluates the Mi-thos transcatheter mitral valve replacement (TMVR) system — a device that replaces a severely leaking mitral heart valve without open-heart surgery. Instead, the new valve is delivered through a catheter, making it an option for older or high-risk patients who are too frail for conventional surgery. The mitral valve is on the left side of the heart and controls blood flow between the heart's upper and lower chambers; when severely leaky, it causes shortness of breath and heart failure. Participants are elderly patients aged 65 or older with severe mitral regurgitation who are not eligible for surgery as determined by a multidisciplinary heart team. The study monitors safety, device performance, and heart function improvement. You may be eligible if... - You are 65 years or older - You have severe mitral valve regurgitation (grade 3+ or 4+) - You are at high surgical risk and your cardiac team has determined you are not eligible for open surgery - You have a life expectancy greater than 12 months You may NOT be eligible if... - You have had prior mitral valve surgery - You have active infections requiring antibiotics - You have severe right heart failure or a left ventricular ejection fraction below 25% - You have severe pulmonary hypertension (pulmonary systolic pressure above 70 mmHg) - You have had a stroke or TIA within the last 30 days - You have a blood clot in the heart Talk to your doctor to see if this trial is right for you.