Smartphone ECG company AliveCor announced the publication of a long-awaited independent trial of the technology conducted by the Cleveland Clinic. As was reported at Heart Rhythm Society in May 2014, the trial showed that AliveCor's heart monitor detected atrial fibrillation that was present 100 percent of the time, and only returned false positives 3 percent of the time.
Researchers at the Cleveland Clinic equipped 60 patients who had recently undergone ablation therapy with both a smartphone-connected AliveCor Heart Monitor and a transtelephonic monitor (TTM), a beeper-sized device that collects ECG data, stores it internally, and can be transmitted to a doctor over a landline. Participants were asked to take their own readings with both devices at regular intervals and whenever they experienced symptoms of atrial fibrillation or atrial flutter.
Although the results speak generally to the accuracy of AliveCor, the study was designed to test the feasibility of AliveCor in that particular use case: patients recovering from ablation therapy for atrial fibrillation. This is especially important as recurrence of atrial fibrillation is common in the first three months after the surgery.
"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,” Khaldoun G. Tarakji, the head researcher on the study, said in a statement. “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.”
Furthermore, the research showed that patients found the AliveCor device easy to use: 92 percent of participants said they would rather use the AliveCor Heart Monitor than the TTM, and only 2 percent reported finding the AliveCor device hard to use.
“We are excited to see independent clinical research that supports the use of the AliveCor Heart Monitor for monitoring post AF ablation patients,” Euan Thomson, president and CEO of AliveCor, said in a statement. “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.”
AliveCor has been making a lot of news in recent months. It launched its FDA-cleared atrial fibrillation detection algorithm at the end of September and the new, third generation of its device just last month. It has also been increasing its reach with various partnerships -- first with GreatCall, which makes smartphones for the elderly, and then with Omron in a distribution partnership that will bring AliveCor devices to various as yet undisclosed retailers.