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
- Type of Study
- Heart & Vascular - Interventional Cardiology Trials
- Short Description
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.
- Principal Investigator
- Mark Reisman, MD
- Eligibility Notes
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%).
- Contact Name
- Inger Rasmussen and Deborah Tinlin, RN
- Alternate Phone
- Alternate Email