Trial Testing Smartwatch to Detect Heart Rhythm Problems

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1 Nov. 2018. A clinical trial is enrolling more than 400,000 participants to test an app written for an Apple smartwatch to detect atrial fibrillation, a form of irregular heart rhythms. The design of the Apple Heart Study, sponsored by Apple Inc., is described in an article appearing today in the American Heart Journal.

The Apple Heart Study is assessing the feasibility of an app on Apple’s smartwatch to detect irregular heart rhythm problems like atrial fibrillation in the population at large. Atrial fibrillation is a disorder where the atria, or upper chambers of the heart, beat irregularly instead of the normal, smooth regular beats that move blood effectively through the blood stream. Because of these irregular heart rhythms, blood can pool in the atria and form clots.

If a clot should break off and flow to the brain, it can cause a stroke. According to American Heart Association, 15 to 20 percent of people who have a stroke also have atrial fibrillation. The authors cite data showing more than 5 million people in the U.S. experience irregular heart rhythms, with as many as 12 million affected with this condition by the year 2050.

The clinical trial, conducted by a team at Stanford University’s medical school in Palo Alto, California, is enrolling a large cross-section of individuals to wear an Apple smartwatch with an app written for the watch. The app screens for signs of irregular heartbeats, and if they occur, participants are asked to wear a specialized electronic sensor called an ePatch to wear for 7 days. The ePatch attaches to the chest and measures a person’s heart rhythms, then are sent remotely to the telemedicine company American Well for collection and analysis.

As of the journal’s publication date, 419,093 individuals enrolled in the study, which stopped accepting new participants on 1 August. The app used in the study has an optical sensor available on the Apple Watch series 1 that analyzes pulse data to identify irregular heart rhythms, which FDA cleared for marketing in September. The agency also cleared at that time an app that conducts an electrocardiogram to measure heart rhythms, but is not used in the study. The ePatch device will provide the electrocardiogram functions.

The Stanford team led by cardiac electrophysiologist Mintu Turakhia and cardiovascular team Marco Perez has 3 objectives in this study: determine if the rate of atrial fibrillation detected by the Apple smartwatch is confirmed by the ePatch device, compare the accuracy of smartwatch irregular pulse detection with ePatch measurements, and track the percentage of individuals who get further medical attention after receiving a notice that they have an irregular heart beat.

“We now have access to high-quality sensors,” says Turakhia in a Stanford statement, “that can measure and detect changes in our bodies in entirely new and insightful ways without even needing to go to the doctor, but we need to rigorously evaluate them. There’s never really been a study like this done before.”

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