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Medtronic Announces CRYSTAL AF Trial Showed Insertable Cardiac Monitors Detect Atrial Fibrillation in Stroke Patients Better Than Standard Care

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Medtronic, Inc. (NYSE: MDT), today announced
results from the CRYSTAL AF (CRYptogenic STroke And underLying Atrial
Fibrillation) Clinical Trial have been published in The New England Journal of
Medicine. The Trial found that continuous cardiac monitoring with the Reveal^®
XT Insertable Cardiac Monitor (ICM) was superior to standard care at detecting
atrial fibrillation (AF) in patients who have had strokes of undetermined
causes (cryptogenic stroke). The global study met its primary endpoint by
demonstrating that continuous monitoring with the Reveal ICM discovered AF in
6.4 times more patients than standard care at six months (p=0.0006).

In addition, the Trial found that compared to standard care (including
electrocardiograms, Holter monitors and other short-term diagnostic tests
prescribed over the follow-up period), the Reveal ICM detected AF in 7.3 times
more patients at 12 months (p<0.0001), and 8.8 times more patients at 36
months (p<0.0001). When followed for 36 months, 30 percent of the patients in
the ICM arm had AF detected. 

"The publication of these data further necessitates the need for us to
reconsider our approach to patients with cryptogenic stroke.  If we can
pinpoint the cause of stroke, we then can apply the most appropriate
treatment," said Prof. Johannes Brachmann, chief of cardiology at the Coburg
Hospital in Coburg, Germany. "As AF is often intermittent and asymptomatic, we
can't rely on symptoms to decide who has AF or who needs ECG monitoring.
Continuous monitoring of the heart rhythm can help us find those stroke
patients whose AF is often missed with short-term monitoring.  This can be
explained by the amount of time that passes between episodes."

One of the reasons that AF can be difficult to detect is that often it is not
associated with symptoms. In the study, 79 percent of the first AF episodes
detected had no symptoms. This means AF likely would have gone undetected by
standard care due to patients' inability to notice warning signs of this
arrhythmia.

Stroke occurs when a blood vessel in the brain ruptures or is suddenly
blocked, which results in damage to the brain tissue. If the cause of a stroke
cannot be determined, the stroke is called "cryptogenic," or a stroke of
unknown cause. Each year in the United States, 795,000 people suffer a stroke,
and it is estimated that 25 to 40 percent of those strokes are cryptogenic in
nature.^[i] Patients with AF (upper chambers of the heart beat very fast and
irregularly), which can be asymptomatic, are five times more likely to have a
stroke.^[ii]

CRYSTAL AF is the largest global randomized clinical trial comparing
continuous monitoring to standard care for the detection of AF in patients
with recent cryptogenic strokes. It is a prospective, controlled trial that
enrolled 441 patients at 55 centers in Europe, Canada and the U.S. from June
2009 to April 2012. The continuous monitoring arm used the Reveal ICM, which
has an algorithm to automatically detect AF as well as other cardiac
arrhythmias. The primary endpoint was time to AF detection at 6 months of
follow-up.

In collaboration with leading clinicians, researchers and scientists
worldwide, 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 around the world. 

Posted-In: News Press Releases

 

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