St. Jude Medical Announces First Implant in Pivotal Phase of Clinical Trial Evaluating AMPLATZER Cardiac Plug for the Prevention of Stroke in Patients with Atrial Fibrillation
ST. PAUL, Minn. — Mar. 8, 2013 — St. Jude Medical, Inc. announced the first patient implant in a new pivotal trial evaluating the company’s AMPLATZER Cardiac Plug (ACP) for the prevention of stroke. The AMPLATZER Cardiac Plug Clinical Trial (ACP Trial) is designed to determine if the ACP device is safe and effective in preventing thrombus from migrating out of the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (AF) who have a high risk for stroke.
The ACP Trial is a prospective, randomized, multi-center clinical study with an adaptive trial design that will enroll no fewer than 400 and no more than 3,000 patients at up to 90 sites in the U.S. and Canada. The trial compares the safety and efficacy of the ACP device to traditional medical treatment using long-term, blood-thinning medication.
Dr. Christian Machado, director of electrophysiology at the Providence Hospital Heart Institute, Southfield, Mich., and investigator in the study, performed the first AMPLATZER Cardiac Plug implant in the pivotal phase of the trial. The procedure was assisted by Dr. Thomas Forbes, a pediatric interventional cardiologist who is also an investigator in the study.
“Patients with untreated atrial fibrillation are four to five times more likely to have a stroke, which greatly increases their risk of disability or death. Dr. Forbes and I consider the ACP Trial an important study as we look for ways to reduce this risk,” said Dr. Machado. “We are excited to contribute research that may help expand treatment options for patients.”
The AMPLATZER device has been the market leader for LAA occlusion since its introduction in 2008. A self-expanding occlusion device constructed from nitinol mesh, and delivered via catheter, the ACP device is designed to completely seal the LAA at its opening, and minimize blood clots from forming in the LAA and migrating into the bloodstream.
Each ACP Trial study site will have physicians who specialize in electrophysiology and interventional cardiology, forming a collaboration between the two specialties.
“The current standard of care for the prevention of stroke is warfarin or other oral blood-thinning medications that can be difficult for some people to tolerate, and may carry a risk of serious complications, such as bleeding,” said Dr. James Hermiller, an interventional cardiologist from St. Vincent Hospital in Indianapolis and ACP Trial investigator. “As physicians, we are always looking for new ways to best treat our patients. We hope the ACP Trial will prove that we can reduce the risk of stroke in patients with atrial fibrillation through this minimally-invasive procedure.”
According to the World Health Organization (WHO), an estimated 15 million strokes occur worldwide each year. In 2010, stroke cost the U.S. an estimated $53.9 billion in health care services, medications and missed days of work. Approximately 87 percent of all strokes are ischemic, which occur when blood clots block the blood vessels to the brain. AF is responsible for approximately 20 percent of ischemic strokes, and about one-third of AF patients will have a stroke in their lifetime if not treated appropriately.
Earlier this year, St. Jude Medical received CE Mark approval and launched the AMPLATZER Amulet™ Left Atrial Appendage Occluder. Considered a next-generation occlusion device, the AMPLATZER Amulet design was driven by feedback from physicians who have been implanting the AMPLATZER Cardiac Plug in Europe since 2008. The Amulet occluder is built with a longer lobe and waist than previous versions to allow for easier placement. The end screw is flush with the disc to create a smooth surface within the left atrium, and the larger disc diameter offers increased orifice coverage. The AMPLATZER Amulet device is offered in eight sizes to accommodate varying anatomies. Additionally, the device is pre-loaded into the delivery catheter, which simplifies device preparation and ultimately streamlines the entire procedure for the physician.
The AMPLATZER Cardiac Plug device is currently not approved for use in the U.S. The ACP Trial is conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA).
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