July 29, 2009 – Transoma Medical Inc., manufacturer of Sleuth AT wireless implantable cardiac monitoring system, today announced the first patient enrollment and 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.
The implant was performed on July 27, 2009, by Safwat Gassis, M.D., 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 David Scher, M.D., director of cardiac electrophysiology for Pinnacle Health System and Associated Cardiologists. The company received FDA 510(k) marketing clearance for Sleuth AT, its next-generation product in February.
“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 is designed for long-term evaluation of AF recurrence after ablation using the Sleuth AT system. The timing and true degree of recurrence in post-ablation paroxysmal AF patients has not been studied until now due to technology limitations. Conventional cardiac monitors that rely on symptomatic activation of ECG storage carry the risk of missing asymptomatic events. Additionally, current external monitoring systems are limited by duration of monitoring and other factors including skin irritation from regular application of electrodes and general patient compliance.
Sleuth AT is the only cardiac monitoring system that allows physicians to program the capture of high-quality ECG strips at frequent intervals, providing a new level of insight into complex arrhythmias that are often asymptomatic and frequently changing, the company said. These captured ECG strips are automatically transferred to a 24/7 monitoring center, staffed by certified cardiac technicians, who analyze, classify and notify physicians of the presence of a wide variety of cardiac arrhythmias, such as ventricular tachycardia, bradycardia, 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.”
For more information: www.clinicaltrials.gov, www.transoma.com