St. Jude Medical (STJ) Announces First Implant in Pivotal Phase of Clinical Trial Evaluating AMPLATZER Cardiac Plug for the Prevention of Stroke in Patients With Atrial Fibrillation
3/8/2013 8:58:35 AM
ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today 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 (blood clots) 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.
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