A new clinical trial seeks to determine which method of monitoring for post-procedure atrial fibrillation (AF) recurrence is more effective while comparing Transoma Medical's (St. Paul, Minnesota) Sleuth AT against external event recorders.
COMPLIANCE is poised to evaluate 140 patients and is a randomized study that is specifically designed to compare how the previously mentioned methods can predict and detect the number of patients who develop recurrent AF at six months, one year and two years after an AF ablation procedure.
"We're hoping that [COMPLIANCE] yields more clinical evidence that continuous monitoring is better than intermittent monitoring," Stella Kim, marketing director for Transoma Medical told Medical Device Daily.
According to the company, external monitoring options provide much 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.
Also 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).
While Transoma isn't sponsoring COMPLIANCE (that honor goes to Dhanunjaya Lakkiredd, MD), the company's stake in the study is the effectiveness of its Sleuth AT, a next generation device that was given FDA clearance back in February (Medical Device Daily, Feb. 17, 2009) and was launched in June.
Lakkiredd who is director of the Center for Excellence in Atrial Fibrillation, Bloch Heart Rhythm Center (Kansas City, Kansas) and associate editor of the Journal of Atrial Fibrillation approached Transoma about using the device in the study.
The Sleuth AT is subcutaneous and sits under the pectoral region and is about the size of a 50 cent piece.
The Personal Diagnostic Manager (PDM) component of Sleuth is a hand-held, multipurpose device that automatically retrieves and stores relevant ECG data from the implanted cardiac monitor (ICM), 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. 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.
It can be programmed to capture a 20-second ECG strip every 7.5 minutes, or every 15 minutes, or every four hours, according to the company. So in essence, if the physician wanted to monitor a patient for complex arrhythmias, including AF, he or she would get a monthly report, looking at the patient for 20 seconds as often as every 7.5 minutes.
Transoma said the system includes an implantable loop recorder, a personal diagnostic manager, a base station and a 24/7 monitoring center operated by Medicomp (Chantilly, Virginia) and staffed by certified cardiac technicians who classify and notify physicians of the presence of a wide variety of cardiac arrhythmias such as ventricular tachycardia, bradycardia, supraventricular tachycardia and AF.
If the cardiac technician observes a particularly concerning arrhythmia, the patient's physician will be contacted immediately, the company said.
"Where our device is different from others is that we have continuous monitoring," Kim said. "The device is also truly wireless unlike other offerings."
Competitors sharing this market include, Medtronic's (Minneapolis) Reveal XT and its Reveal DX insertable cardiac monitors are placed just under the skin of the chest area in a short outpatient procedure, and are also designed to capture an ECG during the actual episode. Another such device is St. Jude Medical's (St. Paul, Minnesota), Confirm ICM - a device is the size of a computer thumb drive.
Transoma maintains that its wireless capabilities help distinguish it from the competition and said that this new study will change and quite possibly redefine the ICM market.
"Being a part of COMPLIANCE is huge for us," Kim told MDD. "There's so much interest in this form of monitoring and we're grateful that Dr. Lakkiredd has included us."
Omar Ford, 404-262-5546;