Medtronic clinical trial aims to evaluate Atrial Fibrillation

Medtronic has announced a new clinical trial that aims to evaluate high risk atrial fibrillation (AF) patients, with key patient predictors to be identified for AF.

A Reveal Insertable Cardiac Monitor (ICM) will be used as part of the work, which is implanted just beneath the skin to continuously record heart activity, with the trial assessing how patients experience AF.

As well as this, the trial aims to review how physicians manage patients after AF has been diagnosed, while identifying how the disease can be detected earlier in the continuum of care.

In the quantitative analysis, 400 patients from around 60 centres in the US and Europe will be implanted with a Reveal ICM, which can transmit information from the patient's ear via Medtronic's CareLink network, allowing physicians to review patient data remotely.

AF stands as the most common heart arrhythmia, affecting over three million Americans and seven million people across the world, though it can be difficult to diagnose as it can occur infrequently and patients may not experience symptoms when an episode is ongoing.

Dr Eugene Parent, attending cardiologist and director of echocardiography at the Bradenton Cardiology Center and Manatee Memorial Hospital in Bradenton, said: "As a cardiologist I am quite concerned about the risks and complications of atrial arrhythmias, especially thromboembolic complications of atrial fibrillation.

"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."

Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic, said that AF can cause a five-fold increase in the risk of stroke, with the condition carrying significant burdens for patients and the healthcare system.

"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," they added.

Posted by Fiona Griffiths