January 6, 2010 – Two validation studies for a wireless, hand-held, patient-activated device that records and transmits reconstructed 12-lead ECGs confirmed the product's ability to accurately provide remote patient monitoring.
The goal of the studies was to validate the performance of the CardioBip-transmitted 12-lead ECGs when compared to conventional 12-lead ECGs. The first study validated the performance in remote monitoring of acute ischemic events. The second study analyzed the use of CardioBip for remote monitoring of patients undergoing atrial fibrillation (AF) treatment. The studies were conducted by the Clinical Center of Serbia and by the Dedinje Cardiovascular Institute, both located in Belgrade, Serbia.
The device uses fully integrated electrodes and requires no wires to acquire the signal. The signals are transmitted via wireless telephony to a call center where 12-lead ECGs are reconstructed using proprietary algorithms.
In the first study, 47 subjects with angiography-documented coronary artery disease were monitored for ST-segment changes during exercise treadmill testing. Conventional 12-lead ECGs were recorded simultaneously with CardioBip transmitted signals prior to and post exercise. Conventional 12-lead ECGs were treated as the gold standard.
Two blinded expert cardiologists determined the number of patients with positive events, the number of leads with positive events and identified the lead that displayed most numerous positive events. Based on all these three criteria, independent statistical analyses showed the detection rate of exercise-induced acute ischemia by the CardioBip system was equivalent to that obtained by conventional 12-lead ECG analysis.
In the second study, 18 patients with persistent AF undergoing elective electrical DC cardioversion were studied. One to three wireless 12-lead ECG CardioBip transmissions were performed three to seven days before and up to two weeks after cardioversion. Atrial activity seen in the CardioBip transmitted traces was compared to that determined by conventional 12-lead ECGs in both sinus rhythm and AF.
The two blinded expert cardiologists analyzed the number of leads with visible P waves, the P wave polarity and the number of leads with clear AF signal. Independent statistical analyses showed that 12-lead ECGs transmitted with CardioBip and conventional 12-lead ECGs had equivalent performance.
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