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UPMC has been selected as a center for the COAPT (Cardiovascular Outcomes Assessment of the MitraClip® Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) Continued Access Study (CAS). COAPT CAS is an extension of the COAPT Randomized Control Trial, a clinical evaluation of the safety and effectiveness of the MitraClip® system for treatment of functional mitral regurgitation in symptomatic heart failure subjects.
In the United States, the MitraClip® is not FDA-approved for use in patients with functional mitral regurgitation. However, there is FDA approval for patients with moderately severe to severe degenerative mitral regurgitation who are at prohibitive risk for surgery.
Mitral regurgitation has an increased incidence and prevalence with increasing age. Historically, older adult patients have more comorbidities that may make them high risk for standard surgical approaches to MR. Functional MR – based on an abnormality in the left ventricle and not the valve – can also be challenging for surgeons to effectively treat. When MR surgery is not indicated due to high surgical risk, additional measures, including investigational interventional therapies, may be recommended.
The COAPT CAS, a single arm registry, will continue to evaluate the safety and effectiveness of the MitraClip® system and provide additional supportive clinical evidence for the MitraClip® proposed indication expansion. The COAPT RCT randomized patients to compare the percutaneous edge-to-edge repair clip with traditional treatments. For COAPT CAS patients are not randomized. All patients will be eligible to receive the MitraClip if they meet criteria.
The percutaneous endovascular system allows placement of a clip without cardiopulmonary bypass or chest incision. The clip placement procedure is based on an existing surgical technique (the Alfieri repair). The clip is intended to be placed on the mitral valve, creating a double inlet valve and reducing mitral regurgitation.
Potential candidates for the COAPT CAS have the following characteristics:
For a full list of inclusions/exclusion criteria or to refer a patient: