Transoma Medical commences enrollment in its COMPLIANCE atrial fibrillation clinical trial

Sep 23 2009

Transoma Medical, Inc., manufacturer of Sleuth AT^™, the only wireless, automated implantable cardiac monitoring system with programmable and frequent electrocardiogram (ECG) sampling, announced today the first enrollment and implant in the COMPLIANCE trial, a long-term study to compare external event recorders with implantable monitors in patients who have been prescribed catheter ablation therapy for atrial fibrillation (AF) at risk of post-procedure AF recurrence. Dr. Dhanunjaya Lakkireddy performed the first implant at the University of Kansas Medical Center, Kansas City, Kansas. Dr. Lakkireddy, director of the Center for Excellence in Atrial Fibrillation, Bloch Heart Rhythm Center, and associate editor of the Journal of Atrial Fibrillation, is the principal investigator for the clinical study. The company received FDA 510(k) marketing clearance for Sleuth AT, its next-generation product, in February 2009.

“I am very excited about the potential for Sleuth AT to provide a unique method of long-term cardiac monitoring for AF recurrence after ablations,” said Dr. Lakkireddy. “The COMPLIANCE clinical trial will help compare cost-effectiveness and efficacy of external versus implantable monitoring after ablation of AF. We hypothesize that implantable loop recorders are superior in detection of atrial arrhythmias after AF ablation, and are much more cost effective and more user friendly, facilitating patient compliance.”

The COMPLIANCE trial (Comparison of External Event Recorders with Implantable Monitor for Post Atrial Fibrillation Monitoring. Assessment of Cost and Efficacy) is a randomized study that is designed to compare the number of patients who develop recurrent AF at six months, one year and two years of an AF ablation procedure between the conventional external monitoring (combination of non-looping and looping event recorders), and implantable loop recorders. The study will collect and analyze information on the percentage of patients who develop stroke symptoms, and their medication use, quality of life, and time to diagnosis of the recurrence of AF between event recorders and implantable loop recorders to estimate cost effectiveness. The study will enroll 140 patients.

“Current external monitoring options provide 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,” said Dr. Lakkireddy. “Often times, it is very inconvenient for patients to wear external event recorders. Many patients also have allergies to the sticky pads that are needed for most of the external monitoring devices. Implantable loop recorders have the advantage of detecting symptomatic and asymptomatic AF continuously. They also offer the convenience of monitoring for up to 18 to 24 months without significant patient discomfort.”

Earlier studies have shown that conventional monitoring methods cannot detect AF in all cases, and that a prolonged duration of monitoring is required to effectively measure the absence or presence of AF post-ablation. Due to the asymptomatic and transient nature, paroxysmal (sudden onset) atrial fibrillation detection does not often occur within the bounds of the Holter monitors, event recorders or mobile out-clinic monitoring systems (MCOT). Addressing such diagnostic limitations, the Sleuth AT System provides implantable ECG monitoring, with wireless automatic event reporting. ECGs are periodically collected (up to eight times an hour).

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. 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.

“Since clearance of the Sleuth AT system, we have seen tremendous interest in long-term monitoring of patients after AF ablation procedures, both by electrophysiologists performing catheter ablations as well as cardiac surgeons performing surgical ablations,” 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 the effects of current and future therapies.”

www.transoma.com