EFS of the CardioMech MVRS

This study evaluates the CardioMech Mitral Valve Repair System (MVRS), a new device designed to repair a leaky mitral valve — one of the four valves in the heart — without open-heart surgery. The mitral valve can become leaky (regurgitant) when it prolapses (bulges backward) or has a flail leaflet (a part of the valve that breaks free and flaps). This causes blood to flow the wrong way in the heart, which over time can weaken the heart muscle. The CardioMech device is implanted through a catheter (a thin tube), making it a much less invasive procedure than traditional surgery. This study (an Early Feasibility Study, EFS) tests whether the device is safe and feasible in patients who are at intermediate or high surgical risk. You may be eligible if: - You are 18 years of age or older - You have moderate-to-severe or severe mitral valve regurgitation caused by valve prolapse or a flail leaflet - You are at intermediate or high risk for open-heart surgery You may NOT be eligible if: - You have rheumatic heart disease or prior endocarditis - You have had a previous mitral valve repair or replacement - Your mitral valve leaflets are heavily calcified or otherwise unsuitable for repair - Your valve problem is due to a complex mechanism (perforation, severe calcification, multiple segments involved) Talk to your doctor to see if this trial is right for you.