Transoma Medical, Inc. announced the enrollment and first patient implant in a long-term study to monitor patients who have been prescribed catheter ablation therapy for atrial fibrillation (AF) at risk of recurrence of AF after the procedure. On July 27, 2009 the implant was performed, by Dr. Safwat Gassis, a cardiac electrophysiologist with Associated Cardiologists in Harrisburg, Pa. The primary investigator for the study at Harrisburg Hospital, part of the Pinnacle Health System, is Dr. David Scher, director of cardiac electrophysiology for Pinnacle Health System and Associated Cardiologists. On Feb 11, 2009 the company received FDA 510(k) marketing clearance for Sleuth AT.
“I am very excited about the potential for Sleuth AT in terms of providing a unique method of long-term cardiac monitoring for AF recurrence after ablations,” said Dr. Scher. “Previous monitoring options provided shorter monitoring durations or limited memory capacity, which is not ideal when trying to determine appropriate ongoing therapy for my AF patients who have undergone catheter ablation. Due to the nature of paroxysmal atrial fibrillation, it may remain undetected by standard diagnostic methods. In addition, most atrial fibrillation episodes following catheter ablation occur without symptoms. With Sleuth AT, we can continuously monitor the patient for AF over a prolonged period (up to two years) to determine if, when and for how long AF is present.”
The IMAGINE (Implantable Monitoring for AF Ablation Generating Insight and New Evidence) clinical study evaluates AF recurrence after ablation using the Sleuth AT system on long-term basis. Due to technology limitations, the true degree of recurrence and timing in post-ablation paroxysmal AF patients has not been studied yet. The cardiac monitors which rely on symptomatic activation of ECG storage carry the risk of missing asymptomatic events.
Sleuth AT is a cardiac monitoring system which allows physicians to program the capture of high-quality ECG strips at frequent intervals thus providing a new level of insight into complex arrhythmias which are often asymptomatic and frequently changing. All these captured ECG strips are automatically transferred to a 24/7 monitoring center, staffed by certified cardiac technicians those who analyze, classify and notify physicians of the presence of a wide variety of cardiac arrhythmias, such as, bradycardia, ventricular tachycardia, supraventricular tachycardia and AF.
“The IMAGINE study will provide us with information that we’ve never been able to access before,” said Dr. Steven Rothman, principal investigator for the study from Lankenau Hospital, Main Line Health Heart Center in Wynnewood, Pa. “The data from this study will allow us to take a new look at atrial fibrillation post-ablation and to evaluate the best course of action regarding future treatment. Continuous, long-term rhythm monitoring in AF patients is indispensible to define the true absence, presence and burden of the arrhythmia.”
“Since clearance of the Sleuth AT system, interest in long-term monitoring of patients after AF ablation procedures, both by electrophysiologists performing catheter ablations and cardiac surgeons performing surgical ablations, has been tremendous,” said Brian Brockway, Transoma Medical founder and CEO. “Physicians are looking for a continuous monitoring system that provides improved detection and monitoring capabilities over existing options while minimizing patient compliance issues. We believe Sleuth AT is a unique and superior method for monitoring AF and efficacy of current and future therapies.”