This clinical trial is for men and women diagnosed with clinically significant functional mitral regurgitation who are determined to have an unacceptably high risk from surgery.
The purpose of the study is to evaluate the safety and effectiveness of the MitraClip System made by Abbott Vascular, Inc. The MitraClip System is the first FDA-approved mitral valve repair therapy that is percutaneous, meaning that access to the heart is gained by means of a catheter, as with angioplasty or stenting, rather than by an open heart surgery. This provides a treatment option for select patients with mitral regurgitation.
Study subjects will be randomized in a 1:1 ratio either to receive the MitraClip device, or to be treated without the device by standard medical care. Study subjects are followed up for 5 years.
Men and women age 18 and older who are diagnosed with moderate-to-severe or severe symptomatic functional mitral regurgitation and are deemed too high risk to undergo mitral valve surgery may enroll in the study. Eligibility is determined by a multidisciplinary team involving cardiologists and cardiothoracic surgeons.
Detailed eligibility requirements will be reviewed when you contact the study team.
Dolores Reynolds, R.N., phone 212-746-4617, email firstname.lastname@example.org
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation. ClinicalTrials.gov Identifier NCT01626079