Trial ID or NCT#

NCT01626079

Status

RECRUITING

Purpose

The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe functional mitral regurgitation.

Official Title

A Clinical Evaluation of the Safety and Effectiveness of the MitraClip® System for the Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Sean Mackey, MD, PhD
Pain management specialist, Anesthesiologist
Redlich Professor and Professor, by courtesy, of Neurology at the Stanford University Medical Center
Rajesh Dash, MD, PhD, Medical & Scientific Director, SSATHI
Cardiologist
Assistant Professor of Medicine (Cardiovascular Medicine) at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

CONTACT

Zoe Magee
(650) 725-2687