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Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve

Purpose of trial:

The purpose of this study is to compare the safety and effectiveness of The Coapsy device to standard therapy when used to treat patients with moderate to severe mitral regurgitation

Protocol Summary:

This study is being done to compare the safety and effectiveness of the Coapsy device versus the standard therapy for patients with moderate to severe mitral valve regurgitation. The Coapsy device is a permanently implantable device. Patients are randomized to either the treatment group ( which will receive the device) or the control group which will not receive the device. The procedure is done by inserting a flexible chord through the heart. A pad is place on each end of the chord. The pads are pulled toward one another, decreasing the distance between the pads. Pulling the chords together is intended to change the shape of the valve and to reduce the leak. It is not ecessary to stop the heart from beating during the Coapsy rocedure, however the patient is schedule to have coronary artery bypass grafting at the same time, the heart may be stopped during the procedure. Our goal is to improve treatment for mitral valve regurgitation. There will be required testing before the procedure to see if the patient ualifies for the surgery, also before discharge and at different periods post-op according to the protocol, testing will be done to evaluate the patients cardiac function. This study is being funded by Myocor, Inc

Sponsoring Department: Surgery - Division of Cardiothoracic Surgery
Sponsoring Company: Myocor, Inc.
Investigator: Carl Arentzen, MD
Number of other sites in trial: SIU School of Medicine; Memorial Medical Center, St. John's Hospital
Basic Eligibility Criteria: Participants must have moderate to severe mitral valve regurgitation
Age: 18 years of age or older
Study Coordinator: Cyndi Deitrick, MD
Number of visits required:  
SCHIRS Protocol Number:  
Contact Person: Contact Person: Theresa Boley, RN, MSN, APN/FNP
Contact Phone: 217-545-5000
Contact Email: tboley@siumed.edu

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Updated May 10, 2006