COAPT Continued Access Study (CAS)
Study Type/Phase: III
Status: Not Recruiting
The COAPT Continued Access Study (CAS) is an extension of an initial trial, “The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional MR (COAPT) trial”, at El Camino Hospital. The initial study was a randomized, parallel-controlled, multicenter study that enrolled 610 subjects and is now in follow-up. The purpose of the COAPT CAS study is to continue to evaluate the safety and effectiveness of the MitraClip NT System in patients with a type of mitral regurgitation (MR) that is not felt to be appropriate for mitral valve surgery.
The mitral valve is located between the left atrium (upper heart chamber) and left ventricle (lower heart chamber). Functional MR occurs when the two leaflets of your mitral valve do not close properly causing blood to leak backward from the left atrium to the left ventricle with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward.
A maximum of 800 patients from up to 75 medical centers in the US who previously enrolled patients in the randomized trial of COAPT will participate in this Study. El Camino Hospital was one of these sites and participation in the CAS study means you must also participate in the national Transcatheter Valve Therapy Registry (TVT Registry), which is owned and operated by the American College of Cardiology Foundation (ACCF) and The Society for Thoracic Surgeons (STS). Your treating hospital is a national TVT Registry site.
Participants will be followed up by a study doctor and his/her staff at 30 days and 1 year following your mitral valve implant. Your clinical information will be collected in the TVT Registry database. Follow-up will continue for five years through linkage with the Centers for Medicare and Medicaid Service (CMS) Claims database based on the claims submitted by your treating hospital and doctor.
If you think you are a candidate for Mitral Valve replacement, speak with your doctor to determine whether you meet the criteria for participation in this study.