(March 1, 2016, Bryn Mawr, PA) – Bryn Mawr Hospital, part of Main Line Health’s Lankenau Heart Institute, is the first center on the East Coast to enroll patients in the FDA-approved AMAZE clinical trial that is studying left atrial appendage (LAA) closure with the LARIAT Suture Delivery Device as an adjunct to ablation in patients with persistent and long-standing persistent atrial fibrillation (AF).
“This is a milestone in the treatment of atrial fibrillation” said Sheetal Chandhok, MD, Bryn Mawr Hospital cardiologist, part of Lankenau Heart Institute, who is one of the primary investigators and the first physician on the East Coast to enroll a patient in the trial. “AF is a life-changing disorder that causes devastating consequences, including stroke and congestive heart failure. Using the LARIAT device as an adjunct to conventional ablation could become the standard of care option for patients with persistent and/or long-standing persistent AF. Current ablation strategies for persistent atrial fibrillation which target the pulmonary veins are only successful between 20-40% of the time. The LAA has recently been shown to be an important trigger for atrial fibrillation and ablation of the LAA has been successful in reducing atrial fibrillation. The LARIAT device provides complete closure and electrical isolation of the LAA without the risks and difficulty associated with ablation, thus eliminating a potential source of AF.”
AF is an irregular heartbeat, a rapid heartbeat, or a quivering of the upper chambers of the heart, called the atria, due to a malfunction in the heart’s electrical system. It is the most common heart rhythm disorder in the United States, affecting more than 5 million people. By causing rapid and irregular heart beats, AF can lead to fatigue, shortness of breath, palpitations, chest pain and weakening of the heart muscle called cardiomyopathy. In addition, atrial fibrillation can lead to two potentially life-threatening conditions: stroke and congestive heart failure.
“Lankenau Heart Institute’s participation in this trial is a testament to our commitment to serve as a leader in the prevention and treatment of cardiovascular disease in the region,” says William Gray, System Chief of the Division of Cardiovascular Disease at Main Line Health and President of Lankenau Heart Institute. “The AMAZE trial enables us to study the benefits of using advanced technology to offer AF patients a treatment option that has the potential to improve quality of life by restoring normal electrical function of the heart. This is one example of the many research endeavors that Lankenau Heart Institute participates in as we work with our colleagues at other renowned institutions across the country to advance the field of cardiovascular medicine.”
In a recently published study, the LARIAT used as an adjunct to ablation in patients with persistent or long-standing persistent AF showed a 65 percent freedom from AF at 1 year versus 39 percent in patients with ablation only. Other studies have demonstrated that the LARIAT device not only closes the LAA mechanically, but can also isolate electrical activity within the LAA, a known trigger for AF, shown to contribute abnormal electrical activity in a significant percentage of patients. The objective of the AMAZE trial is to demonstrate that the LARIAT will reduce or eliminate these LAA triggers and when combined with PVI ablation will lead to a reduced incidence of recurrent AF compared to ablation alone, with a high safety profile.
The LARIAT is a permanent, non-implant solution to LAA closure that is being studied for its capabilities to both mechanically and electrically isolate the LAA in patients with AF. The LARIAT utilizes remote suture delivery to close the LAA from the outside of the heart in a precise and controlled manner without open surgery.
The AMAZE trial is a rigorously designed study to validate the mechanical and electrical isolation benefits of the LARIAT device. The study is comprised of two stages. The overall study plan is to enroll a maximum of 600 persistent or longstanding persistent AF patients who are candidates for PVI catheter ablation at up to 50 centers. The first stage of the AMAZE Trial will enroll up to 175 patients at 15 centers.
About Main Line Health
Founded in 1985, Main Line Health (MLH) is a not-for-profit health system serving portions of Philadelphia and its western suburbs. At its core are four of the region’s respected acute care hospitals—Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital—as well as one of the nation’s premier facilities for rehabilitative medicine, Bryn Mawr Rehab Hospital; Mirmont Treatment Center for drug and alcohol recovery; and HomeCare & Hospice, a home health service. Main Line Health also consists of Main Line HealthCare, one of the region’s largest multi-specialty physician networks, and Lankenau Institute for Medical Research, a non-profit biomedical research organization located on the campus of Lankenau Medical Center. Main Line Health is also comprised of four outpatient health centers located in Broomall, Collegeville, Exton and Newtown Square. Main Line Health Hospitals, with more than 10,000 employees and 2,000 physicians, are the recipients of numerous awards for quality care and service, including System Magnet® designation, the nation’s highest distinction for nursing excellence. Main Line Health is among the area’s leaders in medicine, providing advanced patient-centered care, education and research to help our community stay healthy.
About Lankenau Heart Institute
Lankenau Heart Institute is Main Line Health’s premier, comprehensive cardiovascular medicine and surgery program. Lankenau Heart Institute brings together the clinical expertise of all four of Main Line Health’s acute care hospitals and community cardiology practices to ensure that patients receive a level of quality, service and experience that is unprecedented in the region. Through the Systemwide coordination of services, Lankenau Heart Institute delivers preventive, diagnostic, therapeutic and rehabilitative cardiovascular services at each of our locations, including Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital.
With a collaborative team of expert consultative cardiologists, interventional cardiologists, electrophysiologists, cardiovascular surgeons and specially trained nurses and technologists, the Lankenau Heart Institute is dedicated to managing and treating patients with heart failure, aortic disease, coronary and peripheral vascular disease, heart rhythm disorders and valve disease. Our team of cardiologists and cardiac specialists provide patients and their families with expert cardiac care, close to home.