Clinical Area Interventional Cardiology/Investigational Devices
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.