Until recently, high-risk heart patients with a severe form of leaky mitral valve disorder, called mitral regurgitation, and who were deemed too frail or sick to undergo open heart surgery had few treatment choices.
Now, because of Cooper Heart Institute’s (CHI) expertise in performing minimally invasive valve techniques and clinical research experience, the CHI is one of 75 testing sites in North America and the only site in South Jersey to be taking part in a clinical trial – the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial — to evaluate the effectiveness of a minimally invasive, catheter-based procedure that uses a clip to repair the leakage.
“We are very fortunate to be able to participate in this multi-center trial,” said, Janah Aji, MD, Director of the Cooper Cardiac Catheterization Laboratory, who serves as principal investigator of the COAPT trial at Cooper. “It can be a life-changing option for local patients suffering with severe mitral regurgitation.”
“Following this procedure, patients who have severe heart failure symptoms due to this condition may experience significant improvement in shortness of breath and fatigue,” noted Dr. Ginsberg.
Mitral regurgitation affects millions of people worldwide. It is the most common type of heart valve defect, affecting one in 10 people aged 75 and older. The condition occurs when the heart’s mitral valve does not close completely, causing blood to leak backward into the left atrium with every heartbeat. Mitral regurgitation requires the heart to work harder to maintain an adequate forward flow of blood. Over time, that can lead to serious heart rhythm problems, stroke, heart attack, heart failure and death.
Patients who meet eligibility criteria are now being enrolled in the study at Cooper. The COAPT trial is a randomized study that will enroll up to 420 patients nationwide. Because it is randomized, half the patients will be assigned to the device group that will receive the MitraClip (along with standard therapy) and half will be assigned to a control group that solely receives standard therapy. All of the study participants will remain in the trial for up to five years to determine if the MitraClip provides benefits over and above standard care alone.
The MitraClip is manufactured by Abbott Vascular. For more information about the Cooper Heart Institute, visit http://www.cooperhealth.org/departments-programs/heart-institute.
Wendy A. Marano