5309W-12 A Clinical Evaluation of the Safety and Effectiveness of the MitraClip® System for the Trea

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.

Status
Open
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
Phone
206-215-3989
Alternate Phone
206-215-2455
Email
inger.rasmussen@swedish.org
Alternate Email
deborah.tinlin@swedish.org