A Clinical Evaluation of the Safety and Effectiveness of the MitraClip® System for the Treatment of Functional Mitral Regurgitation in Symptomatic Subjects who are Extremely High Risk for Mitral Valve Surgery
To evaluate the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation in symptomatic subjects that are extremely high risk for mitral valve surgery.
Heart & Vascular - Interventional Cardiology Trials
John Petersen II, MD
Patients with symptomatic, functional MR (≥3+) due to cardiomyopathy of either ischemic or nonischemic etiology, and considered high surgical risk (the cardiothoracic surgeon at the investigational site assessed a predicted surgical mortality for mitral valve surgery of ≥ 12%).
Charlene Boisjolie and Inger Rasmussen