Medtronic Announces First Patient Implant in REVEAL AF Clinical Trial

MINNEAPOLIS – Medtronic, Inc. 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.

Source: Medtronic, Inc.