EVALVE COAPT: Use of the mitraclip system® in treating both high risk and prohibitive risk surgical candidates with moderate to severe, centralized mitral regurgitation.

Short Description: The purpose of the study is to evaluate the safety and effectiveness of the investigational MitraClip System in patients with moderate-to-severe or severe functional mitral regurgitation (FMR) who have been determined to be too high risk for mitral valve surgery. FMR occurs when the two leaflets of the heart's mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward. Patient eligibility is assessed based on TTE, TEE, diagnostic catheterization, and surgical consultation. The study is randomized on a 1:1 basis, with assignment to either a "control group" that will NOT receive the study device but rather continue with medical therapy only or a "treatment group" that will receive the device (and also continue with medical therapy). Up to 350 patients will participate in this study across North America and will follow-up for 5 years.

Principal Investigator: William A. Gray, MD


Partner II: Placement of aortic transcatheter valves in patients who are at intermediate risk for surgery or who are not surgical candidates

Short Description: The purpose of this trial is to establish the safety and effectiveness of the Edwards SAPIEN device and delivery systems (transfemoral, transapical and transaortic) for use in patients with severe aortic stenosis. There are two cohorts: A) patients at intermediate/high risk for surgical valve replacement and B) inoperable patients. Cohort A is a 1:1 randomized comparison of transcatheter heart valve therapy with traditional, open-heart valve surgery (AVR) in intermediate/high risk patients. The treatment arm will receive the SAPIEN XT via transfemoral, transapical or transaortic access. The control arm will receive a bioprosthetic heart valve via aortic valve surgery. Cohort B (inoperable) is a 1:1 randomized comparison of the first generation system to the second generation. Control arm will receive first generation device and treatment arm will receive second generation device (both transfemorally). In addition there are 6 registries: transapical, transfemoral in small vessels, valve in valve, transaortic, transfemoral for the 29 mm device. and transapical for the 29 mm device.

Principal Investigators: Susheel Kodali, MD Matthew Williams, MD





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