|Clinical Area||Interventional Cardiology/Investigational Devices|
|Study Title||EVEREST II/REALISM|
|Purpose of Research||A Phase II evaluation of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System. Patients with 3 to 4 mitral regurgitation are randomized 2:1 to receive either the MitraClip™ device or open heart surgery to repair the mitral valve. The MitraClip™ device is a percutaneous mitral valve repair system. This is a pivotal trial that will be submitted to the FDA for approval of the device.|
|Participant Description||Patients with 3 to 4 mitral valve regurgitation (moderate to severe mitral valve disease).The study also offers a high-risk arm for patients who have a 12% mortality risk of open-heart surgery.|
|Principal Investigator||James T. Maddux, MD|
|Study Coordinator||Anne Shepard, RN|
|Study Status||Currently in Follow-up.|
The International Heart Institute of Montana is ranked mid-level for enrollment among the 42 participating sites in the United States.