Clinical Trial: Real World Expanded Multicenter Study of the MitraClip® System (REALISM)

Study Status: No longer available
Recruit Status: No longer available
Study Type: Expanded Access




Official Title: A Continued Access Registry of the Evalve® MitraClip® System: EVEREST II Real World Expanded Multicenter Study of the MitraClip System (REALISM)

Brief Summary: Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Clinical follow-up at discharge, 30 days, 6 months, 12 months, and 2-, 3-, 4-, and 5-years. The study consists of two arms: a high risk group and a non-high risk group. Enrollment in high risk arm is ongoing. Enrollment in non-high risk arm concluded in April 2011.