May 23, 2014 — AliveCor Inc. announced studies presented at the Heart Rhythm Society's (HRS) 35th annual scientific sessions expand the growing body of clinical information evaluating the use of the AliveCor heart monitor.
Clinical and Technical Study Summary:
Three abstracts on the use of the AliveCor heart monitor were presented during the conference and continue to reinforce the benefits of using wireless mobile ECG (electrocardiogram) devices.
The iTransmit study, "Evaluating the Efficacy and Feasibility of a Novel Wireless Recording System Using Smartphone in Monitoring Patients After Atrial Fibrillation Ablation Procedure," was led and presented by Khaldoun G. Tarakji, M.D., of Cleveland Clinic. Tarakji and his team reported that the AliveCor heart monitor had 100 percent sensitivity and 95 percent specificity at detecting atrial fibrillation (AF) after an ablation procedure compared to a standard transtelephonic event monitor. The study was conducted with 38 patients with diagnosed AF undergoing pulmonary vein isolation.
Another study with pediatric cardiology patients, the SPEAR trial ("Smartphone Pediatric Electrocardiogram Trial"), was presented by Hoang Nguyen, M.D., with senior author Jennifer Silva, M.D., from Washington University in St. Louis. This prospective trial evaluated the use of the AliveCor heart monitor in 30 patients with potential and diagnosed arrhythmias. Preliminary data demonstrated that the heart monitor can generate accurate tracings in the remote setting in the pediatric population. In addition, patient and parent experience with the device was overwhelmingly positive; 95 percent of survey responses indicated the device was easy to use and 95 percent prefer to continue using the device once the study ends.
A third study, "Wireless Smart Phone Equipped ECG Enables Large Scale Screening in Diverse Populations," presented by Zach Haberman with senior author Leslie Saxon, M.D., at the University of California Irvine and the USC Keck School of Medicine, evaluated the accuracy of the AliveCor heart monitor when compared to a 12-lead ECG for detecting AF and other cardiac abnormalities. The monitor demonstrated a sensitivity and specificity for the detection of AF/atrial flutter of 94.4 percent and 99.3 percent, respectively. The study was conducted with 382 subjects (USC Division 1 athletes, healthy young adults and electrophysiology clinic patients).
"The clinical benefits of the AliveCor heart monitor were well-represented at HRS 2014. Data presented supports the accuracy and patient satisfaction of our device," said Euan Thomson, president and CEO at AliveCor. "We look forward to working with our customers to learn from their experiences within the cardiac health community and further drive innovation for helping more patients."
The AliveCor heart monitor is the only U.S. Food and Drug Administration (FDA)-cleared mobile ECG recorder that supports both iPhone and Android mobile devices. It records, displays (when prescribed or used under the care of a physician), stores and transfers single-channel ECG rhythms wirelessly using the free AliveECG app. AliveCor does not recommend use of the AliveCor heart monitor for any pediatric patient weighing 10 kilograms or less. With secure storage in the cloud, users can access their data confidentially anytime, anywhere, and can grant access to their physician. The heart monitor is available for purchase in the United States by health professionals and consumers.
For more information: www.alivecor.com