Medtronic announced on 16 January 2013 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 – 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 Eugene Parent, attending cardiologist and director of echocardiography at the Bradenton Cardiology Center and Manatee Memorial Hospital in Bradenton, USA. “Frequently these rhythm changes are difficult to detect. The Reveal AF study will use the Reveal insertable cardiac monitor 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 centres in the United States and Europe will be implanted with a Reveal insertable cardiac monitor. 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 six 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 insertable cardiac monitors in detecting atrial fibrillation so that early-stage therapeutic decisions can be made to improve each patient’s quality of life.”
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 analyses 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.