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St. Jude Medical, Inc.
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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