Medtronic, Inc. MDT today announced
the first patient implant for the REVEAL AF (Incidence of AF in High Risk
Patients) Clinical Trial, which through continuous cardiac monitoring will
evaluate the incidence of atrial fibrillation among patients suspected to be
at a high-risk for the disease, and will identify key patient predictors for
detection of AF.
Using the Reveal^® Insertable Cardiac Monitor (ICM) - a thin device implanted
just beneath the skin that continuously records heart activity - the trial
will assess how often patients experience atrial fibrillation that lasts six
minutes or more, a key measure in determining the incidence of AF in the
trial. The trial also will evaluate how physicians manage these patients once
atrial fibrillation has been diagnosed, and will identify how the disease can
be detected in patients earlier in the continuum of care.
In the study, 400 patients from approximately 60 centers in the United States
and Europe will be implanted with a Reveal ICM. The Reveal device will
transmit information from the patient's heart via Medtronic's CareLink^®
network, thereby allowing physicians to review patient data remotely. Each
patient will be followed for a minimum of 18 months to monitor for atrial
fibrillation and have in-office visits every 6 months.
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