Transoma Medical Enrolls First Patient in Clinical Study Comparing Use of External Recorders with Implantable Monitors to Track Recurrence of Atrial Fibrillation

ST. PAUL, Minn.-(Business Wire)-September 22, 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.”

About Atrial Fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia (abnormal heart rhythm) affecting about 2.2 million Americans. The risk of having AF increases with age, with 3 to 5 percent of people over the age of 65 and 8 percent of people over 80 having AF. During AF the two upper chambers of the heart (atria) quiver instead of beating in coordinated contractions. This inefficient pumping of the heart means blood isn’t always pumped completely out of the atria sometimes resulting in pooling and blood clots (thrombi). If a clot in the atria leaves the heart and becomes lodged in an artery in the brain, a stroke results. Blood clots are the most life-deteriorating consequence of AF.

Many AF patients suffer from symptoms, such as palpitations and heart pounding. This is caused by irregular impulses that are conducted to the lower chambers of the heart (ventricles) that generate the heartbeat. The result is an irregular heartbeat, which may occur in episodes lasting from minutes to weeks, or it could occur all the time for years. The natural tendency of AF is to become a chronic condition; AF begets AF. In many cases, atrial fibrillation is asymptomatic and, therefore undetected by the patient. People with AF usually have a significantly increased risk of stroke (up to seven times that of the general population).

AF patients are generally treated with medications, which either slow the heart rate or revert the heart rhythm back to normal. Catheter-based therapies may also be used to prevent recurrence of AF in certain individuals. People with AF are often given anticoagulants (blood thinners) to protect them from stroke.

The Sleuth AT System

The Implantable Cardiac Monitor is a small, thin device, about the size of a 50-cent piece (or the size of the smallest pacemakers), which continuously monitors the electrical activity of the heart, the ECG. The cardiac monitor is implanted under the skin during a brief, simple, outpatient procedure.
The Personal Diagnostic Manager (PDM) is a hand-held, multipurpose device that automatically retrieves and stores relevant ECG data from the implanted cardiac monitor, securely relays the information to the base station and then to the monitoring center. The PDM is also used by the physician to program the implanted cardiac monitor and even to view non-transmitted ECGs immediately after capture. Data are collected in three ways:
- Patients who experience symptoms, such as lightheadedness, can press a button on the PDM which tells the system to store the patient’s ECG strip during the time of the symptom.
- The system automatically captures and stores the ECG strip when the patient’s heart rate is above or below physician-programmed limits.
- The system can be programmed to capture regular ECG strips every four hours, 15 minutes or 7.5 minutes
At the third-party Monitoring Center, certified cardiac technicians review the patient’s ECG data and provide information to the physician to aid in diagnosis and ongoing treatment. Physicians can access this information via a secure Web portal, and have the reports faxed or e-mailed to them as they prefer. If the cardiac technician observes a particularly concerning arrhythmia, the patient’s physician will be contacted immediately.

About Transoma Medical

Transoma Medical, Inc., headquartered in St. Paul, Minnesota, is a medical technology company engaged in developing, manufacturing and distributing implantable, wireless diagnostic and monitoring products. Transoma is focused on monitoring systems that provide physicians with vital signs information important to accurately diagnose and monitor various forms of cardiovascular disease, and to optimize drug, interventional, surgical and device treatment alternatives. For more information, visit the company’s Web site at www.transoma.com.

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