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Jewish Hospital selected for clinical trial for minimally invasive treatment of functional mitral regurgitation

Published on February 28, 2015

Jewish Hospital, part of KentuckyOne Health, has been selected as one of 75 facilities in the U.S. and Canada that will study MitraClip, an investigational device in patients who have functional mitral regurgitation (MR) and are considered extremely high-risk for mitral valve surgery.

The trial, Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional MR (COAPT trial), is a prospective, randomized, parallel-controlled, multicenter clinical evaluation of the MitraClip device for the treatment of clinically significant functional MR in symptomatic heart failure patients who are treated with current standard of care and who have been determined by the hospital’s heart team as not appropriate for mitral valve surgery. 

MR occurs when the mitral valve of the heart doesn’t close tightly resulting in the leakage of blood backward through the mitral valve each time the left ventricle contracts.

The MitraClip is a small metal clip that treats patients with MR, a condition where the heart’s mitral valve leaflets do not close tightly, allowing blood to leak into the heart’s left atrium and can lead to advanced heart failure. The clip is delivered through the femoral vein with a catheter by a team of physicians, which includes an interventional cardiologist and a cardiovascular surgeon.

“We are pleased to have been selected for participation in the COAPT trial,” said Michael Flaherty, M.D., Ph.D., principal investigator, assistant professor of Medicine, director Adult Structural Heart Disease at University of Louisville and a cardiologist at UofL Physicians. “Sharing expertise through clinical trials and collaboration gives us more options to treat critical patients and improve quality of life for those who would otherwise be out of options.”

The MitraClip procedure shortens recovery time and ultimately improves quality of life for those experiencing life-altering symptoms from MR, like fatigue, shortness of breath, heart murmur and swelling of the feet or ankles.

“For patients with MR, their condition can limit their daily activities and negatively impact their quality of life,” said Brian Ganzel, M.D.,  associate professor, Thoracic & Cardiovascular Surgery Division, Department of Surgery, University of Louisville, and a cardiovascular and thoracic surgeon at UofL Physicians. “Having an option to treat these patients with a procedure that does not require a long recovery and can improve their quality of life is very exciting.”

The COAPT trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip for symptomatic heart failure patients with moderate-to-severe or severe functional MR.  

“Advances in minimally invasive heart procedures directly benefit our patients,” said Kendra Grubb, M.D., MPH, assistant professor, Thoracic & Cardiovascular Surgery Division, Department of Surgery, University of Louisville, and a cardiovascular and thoracic surgeon at UofL Physicians. “By participating in the COAPT trial, we have the opportunity to add to the body of research on the effectiveness of MitraClip.”

KentuckyOne Heart Care throughout the Commonwealth is sharing expertise through clinical trials and advancements in minimally invasive heart care.

In October of 2013, as part of the COAPT Trial, KentuckyOne Health Cardiology Associates physicians, Nezar Falluji, MD, and Michael Schaeffer, MD, along with KentuckyOne Health Cardiothoracic Surgery Associates physician, Robert Salley, MD, performed the first MitraClip procedure in Kentucky at Saint Joseph Hospital. Since that time the team at Saint Joseph Hospital has performed 16 MitraClip procedures. 

MR is the most common type of heart valve insufficiency in the United States, affecting approximately 4 million people. This condition cannot be medically treated, and previously could only be repaired with open-heart surgery on patients who were otherwise physically healthy.

Individuals with MR, or physicians interested in learning more about the COAPT trial can call 502-588-7600 for information.