Medtronic Announces New Clinical Trial Will Use Continuous Cardiac Monitoring to Evaluate Atrial Fibrillation

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.