UPMC Physician Resources

Now actively enrolling for the Abbott COAPT Continued Access Study

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, it has obtained FDA approval in patients with moderately severe to severe degenerative mitral regurgitation who are at prohibitive risk for surgery. 

Mitral valve repair 

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 treatments are 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. 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. 

Which patients are eligible?

Potential candidates for the COAPT CAS have the following characteristics:

  • Symptomatic functional mitral regurgitation (≥3+) of either ischemic or nonischemic etiology
  • Adequately treated per applicable standards in the judgment of the heart failure specialist investigator
  • Local site heart team and central eligibility committee concur that surgery will not be offered as a treatment option and medical therapy is the intended therapy
  • NYHA functional class II, III, or ambulatory IV

Contact Us

For a full list of inclusions/exclusion criteria or to refer a patient: 

  • Conrad Smith, MD, is the principal investigator at UPMC. If you see a patient you believe may qualify, please call Kathryn Ferchak, PA-C, clinical director, at 412-864-2632 or email MitralCenter@upmc.edu.
  • For more information about additional treatments at the Center for Mitral Valve Disease, please visit www.upmc.com/MitralValve