New Clinical Trial Will Use Continuous Cardiac Monitoring to Evaluate Atrial Fibrillation in High-Risk Patients
2013-01-16 15:03:15 -
Medtronic Announces First Patient Implant in REVEAL AF Clinical Trial
MINNEAPOLIS - January 16, 2013 - Medtronic, Inc. (NYSE: 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.
"As a cardiologist I am quite concerned about the risks and complications of
atrial arrhythmias, especially thromboembolic complications of atrial
fibrillation," said Dr. Eugene Parent, attending cardiologist and director of
echocardiography at the Bradenton Cardiology Center and Manatee Memorial
Hospital in Bradenton, Fla. "Frequently these rhythm changes are difficult to
detect. The Reveal AF study will use the Reveal ICM to detect undiagnosed
atrial fibrillation in patients at high risk for thromboembolic complications
and allow more effective and prompt treatment of these patients."
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.
"Atrial fibrillation is the most common arrhythmia, and with a five-fold
increase in the risk of stroke, the condition carries significant burdens for
patients, as well as on the healthcare system," said Pat Mackin, president of
the Cardiac Rhythm Disease Management business and senior vice president at
Medtronic. "Through this study, Medtronic intends to show the clinical value of
ICMs in detecting atrial fibrillation so that early-stage therapeutic decisions
can be made to improve each patient's quality of life."
Atrial Fibrillation is the most common heart arrhythmia affecting more than 3
million Americans and 7 million people worldwide. The disorder can be
difficult to diagnose, as it can occur infrequently and patients may not
experience symptoms during an episode. Reveal's around-the-clock monitoring, in
contrast with intermittent, external monitoring, can result in earlier and more
reliable diagnosis, which can lead to faster treatment. 
About the Reveal(®) XT Insertable Cardiac Monitor
Placed just under the skin of the chest area in a short outpatient procedure,
the Reveal XT device provides up to three years of continuous heart rhythm
monitoring. Reveal XT captures and stores an electrocardiogram (ECG)
automatically, according to physician-programmed settings. Later, a physician
analyzes the stored information which can be transmitted remotely via the
Medtronic CareLink(®) Network, or viewed during an in-office patient visit.
Clinical data available to the physician includes views of individually stored
ECG episodes, or longer-term trended diagnostic data via Reveal XT's Cardiac
Compass(®) Report, including daily atrial fibrillation burden, patient activity
and average day and night heart rates.
In collaboration with leading clinicians, researchers and scientists, Medtronic
offers the broadest range of innovative medical technology for the
interventional and surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers worldwide.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global
leader in medical technology - alleviating pain, restoring health, and extending
life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from anticipated
 Millennium Research Report; "Global Markets For Atrial Fibrillation
Treatment Devices 2008," March 2008; 1.
 Paul D. Ziegler, MS, Jodi L. Koehler, MS, Rahul Mehra, PhD. Comparison of
continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm.
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Source: Medtronic, Inc. via Thomson Reuters ONE