Study Results from Cleveland Clinic’s iTransmit Study Published in

Heart Rhythm Journal

Clinical Validation for Use of the AliveCor Heart Monitor for Monitoring Post AF Ablation Patients

 SAN FRANCISCO, Calif. January 5, 2015 –Cleveland Clinic and AliveCor, Inc. announced the online publication of study results from Cleveland Clinic’s iTransmit Study, “Evaluating the Efficacy and Feasibility of a Novel Wireless Recording System Using Smartphone in Monitoring Patients After Atrial Fibrillation Ablation Procedure”. The study found that the AliveCor Heart Monitor had 100% sensitivity (also called true positive rate) and 97% specificity (true negative rate) for detecting atrial fibrillation (AF) and atrial flutter, combined, compared to a traditional transtelephonic monitor (TTM).

The fully independent study led by Dr. Khaldoun G. Tarakji of Cleveland Clinic, enrolled 60 patients at the Cleveland Clinic and demonstrated the AliveCor Heart Monitor to be a viable alternative for monitoring AF patients after an ablation procedure. Results were first presented at the Heart Rhythm Society in May 2014 and recently published in HeartRhythm (currently available online and expected in print in the coming months).

AF is the most common arrhythmia. Many patients undergo ablations in order to treat their AF. ECG monitoring after an ablation procedure plays an important role in assessing the success of the procedure and guiding a patient’s course of treatment. As recurrence of AF is not uncommon during the first three months after an ablation, monitoring is extremely important as it can identify high-risk patients who might need a second procedure or antiarrhythmic drug therapy.

“The clinical value of these findings are important as the current options for monitoring patients after AF ablation vary between institutions and are usually patient-specific,” said Khaldoun G. Tarakji, MD, MPH Cleveland Clinic. “Capturing AF and monitoring someone’s heart after an ablation can be extremely challenging and it is imperative to have an easy to use monitor that patients can have access to anywhere and at anytime after an ablation.”

The objective of the study was to assess the feasibility and efficacy of the AliveCor Heart Monitor in monitoring patients after AF ablation by comparing it to traditional TTMs. The study included patients who had an iPhone who were undergoing AF ablation, with or without concurrent ablation for atrial flutter. Each eligible patient was provided an AliveCor Heart Monitor and a TTM and were asked to record ECGs using both monitors simultaneously whenever they had symptoms and on a regular fixed weekly schedule. AliveCor Heart Monitor recordings were wirelessly transfered to a secured email account and TTM recordings were transmitted using landlines. Independent electrophysiologists provided blinded interpretations of each AliveCor Heart Monitor recording and TTM recordings were interpreted by the primary electrophysiologist. Recordings that occurred simultaneously were compared at the end of the follow-up period, and it was found that the AliveCor Heart Monitor could detect sinus rhythm 97% of the time and AF and Aflutter 100% of the time with 3% false positives. When asked which monitor the patient’s would prefer to use if they had an option, the vast majority (92%) chose the AliveCor Heart Monitor.

“We are excited to see independent clinical research that supports the use of the AliveCor Heart Monitor for monitoring post AF ablation patients,” said Euan Thomson, president and chief executive officer of AliveCor. “We believe these findings will have great significance for health providers and AF patients looking for easy-to-use and low-cost methods to monitor their condition.”

The AliveCor Heart Monitor can be purchased at store.alivecor.com, Amazon and Omron Healthcare, a leading manufacturer of home blood pressure monitors.

The AliveCor Heart Monitor is intended to record, store and transfer single-channel ECG rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when prescribed or used under the care of a physician). The AliveCor Heart Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested for and it is not intended for pediatric use. The AliveCor Heart Monitor is compatible with all iOS models and most Android mobile devices. With secure storage in the cloud, users have the ability to access their data confidentially anytime, anywhere.