IRB #

IRB00009290

Title

Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional MR (The COAPT Trial)

Principal Investigator

Saurabh Gupta

Study Purpose

The purpose of this study is to compare the performance of the study device plus optimal drug therapy, to optimal drug therapy alone. The study involves functional mitral regurgitation (MR), where the two leaflets, or flaps, of the mitral valve in the heart do not close properly causing blood to leak backward every time the heart beats.

Medical Condition(s)

Mitral valve (MR) regurgitation
Cardiovascular

Eligibility Criteria

Men and women aged 18+ who have MR
AND
have symptoms due to heart failure despite being treated with currently available therapies
AND
are not appropriate candidates for mitral valve surgery.

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

This study requires about 11 visits to the clinic and will take about 5 years to complete.

Minors Included

No

Contact

Cardiovascular Research
(503) 418-1964

Sponsor

Evalve, Inc. (a subsidiary of Abbott Vascular)

Recruitment End

12/31/2016

Compensation Provided

Yes

Compensation

Subjects will be compensated by OHSU up to $100 per study visit. Subjects may also be eligible for up to $125 per visit for lodging.


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