Transoma Medical Announces First Patient Enrollment In Clinical Study To Evaluate Recurrence Of Atrial Fibrillation Post Catheter Ablation

Main Category: Heart Disease
Also Included In: Cardiovascular / Cardiology;  Medical Devices / Diagnostics
Article Date: 29 Jul 2009 - 21:00 PDT

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Transoma Medical, Inc., manufacturer of Sleuth AT™, the only wireless, automated implantable cardiac monitoring system with programmable and frequent electrocardiogram (ECG) sampling, 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 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. The company received FDA 510(k) marketing clearance for Sleuth AT, its next-generation product, on Feb. 11, 2009.

"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. 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."

"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."

Additional information about the IMAGINE clinical trial is available at http://www.clinicaltrials.gov.

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; 3-5 percent of people over the age of 65 and 8 percent of people over 80 have 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).

Treating AF

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.

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).

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.

Source
Transoma Medical

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