The purpose of the 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. Patients with moderate to severe mitral valve regurgitation who are high risk surgical patients, will be randomized 1:1 to either percutaneous treatment with the MitraClip system or continue with regular medical therapy.
In order to participate you must meet the following criteria:
- Have symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology.
- Be at extremely high-risk for mitral valve surgery.
- Have been adequately treated per applicable standards.
- Have been hospitalized for heart failure related symptoms within past year.
You will be excluded from the study if any of the following criteria apply to you:
- Have chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy.
- Have stage D heart failure.
- Have clinically significant untreated coronary artery disease requiring revascularization.
This is a partial list of inclusion and exclusion criteria.