Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients
This is a study of the MitraClip, percutaneous mitral valve repair system in patients with moderate to severe to severe functional mitral regurgitation who need surgical repair but are deemed not appropriate for surgery. Patients will be randomized in a 1:1 fashion to treatment with the Mitra Clip system or medical management. Patients will be followed by the investigators at 30 days, 6, 12, 18, 24 months and then yearly for up to five years with office visits and echocardiograms. Patients who randomize to medical management can crossover to the treatment arm after 24 months of follow up.
- Study Identifier: 815740
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