This clinical trial is for men and women who are diagnosed with mitral regurgitation (MR), mitral insufficiency or mitral incompetence and are at extremely high risk for open mitral valve surgery.
The purpose of the study is to assess the safety and effectiveness of the MitraClip device, the first device for repair of the mitral valve that is delivered by a catheter, avoiding the need for heart surgery. Half of the eligible study subjects will be randomized to undergo the MitraClip procedure, and the other half will continue to be treated according to standard medical care without the MitraClip procedure.
Study subjects will be followed up for 5 years after placement of the stent.
Men and women age 18 and older with senile degenerative aortic valve stenosis and heart failure assessed at NYHA Functional Class II or greater. Only patients who are determined by the study team to be at extremely high risk for open mitral valve surgery may be enrolled.
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
Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for Extremely High Surgical Risk Patients (The COAPT Trial): A Clinical Evaluation of the Safety and Effectiveness of the MitraClip System for the Treatment of Functional Mitral Regurgitation in Symptomatic Subjects who are Extremely High Risk for Mitral Valve Surgery. ClinicalTrials.gov Identifier NCT01626079