News | February 09, 2015

Cleveland Clinic, AliveCor Release Results of iTransmit Atrial Fibrillation Study

Results offer validation for of AliveCor Heart Monitor for monitoring post-AF ablation patients

AliveCor, Heart Monitor, atrial fibrillation, AF, ECG, Cleveland Clinic, study

February 9, 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-percent sensitivity (also called true positive rate) and 97-percent 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. Electrocardiogram (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, M.D., 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 transferred 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 percent of the time and AF and Aflutter 100 percent of the time with 3 percent false positives. When asked which monitor the patient’s would prefer to use if they had an option, the vast majority (92 percent) chose the AliveCor Heart Monitor. 

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