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.”