Transoma Medical Announces First Patient Enrollment in Clinical Study on Atrial Fibrillation

Study Utilizes Sleuth AT™ Implantable Cardiac Monitoring System to Monitor for Presence of AF after Cryptogenic Stroke. Ohio State University Medical Center Site of First Implant.

Transoma Medical, Inc., manufacturer of Sleuth AT™, the only wireless, automated implantable cardiac monitoring system with programmable and frequent electrocardiogram (ECG) sampling, announced the first enrollment and implant in a long-term study to monitor patients who have suffered a cryptogenic stroke (of unknown origin) to determine if atrial fibrillation (AF) is present. The implant was performed on April 10 by Dr. Emile Daoud, electrophysiologist, at Ohio State University Medical Center in Columbus. The company received FDA 510(k) marketing clearance for Sleuth AT, its next-generation product, on Feb. 11, 2009.

“It is believed that as many as 20 percent of cryptogenic strokes are caused by asymptomatic atrial fibrillation” said Dr. Daoud. “Due to the nature of paroxysmal atrial fibrillation it may remain undetected by standard diagnostic methods and may be an under-recognized cause of cryptogenic stroke. With Sleuth AT, we can continuously monitor the patient for AF over a prolonged period to determine if, when and for how long AF is present.”

The Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation after Cryptogenic Stroke is a pilot study involving five centers in Canada and the United States. The investigators driving this important clinical study are Dr. Andrew Krahn from the London Health Sciences Centre University Hospital in London, Ontario and Dr. Daoud. The primary endpoint of the study is to determine the incidence of AF at one year from Sleuth AT implantation in patients who have had cryptogenic stroke.

Sleuth AT allows physicians to program the capture of high-quality ECG strips at frequent intervals, providing a new level of insight into complex arrhythmias which are often asymptomatic and frequently changing. These captured ECG strips are automatically transferred to a 24/7 monitoring center, staffed by certified cardiac technicians, who classify and notify physicians of the presence of a wide variety of cardiac arrhythmias such as ventricular tachycardia, bradycardia, supraventricular tachycardia and atrial fibrillation.

“It will be very interesting to see the results that come out of this study” said Dr. Geoff Eubank, a neurologist at Neurological Associates, Inc. in Columbus, who frequently treats cryptogenic stroke patients and partners with Dr. Daoud for evaluation of these patients. “Monitoring and diagnostic technology up until now has been limited and sporadic in providing data. I’m hopeful that the long-term, continuous and automated nature of this system will prove more effective in delivering the information we need to effectively treat these patients and prevent future strokes.”

“Having this study underway is a milestone because AF could be the cause of a large number of cryptogenic strokes,” said Brian Brockway, Transoma Medical founder and CEO. “AF is a common cardiac arrhythmia that is challenging to manage. However, we believe Sleuth AT is a unique and superior method for monitoring AF and the effects of current and future therapies.”

Source:  Transoma Medical

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