A clinical trial to determine whether a smartwatch app that analyzes pulse-rate data can screen for a heart-rhythm disorder has enrolled more than 400,000 participants.
Researchers at Stanford Medicine, in collaboration with Apple, launched the Apple Heart Study last November to determine whether a mobile app that uses the optical sensor on the Apple Watch to analyze pulse rate data can identify atrial fibrillation. The condition, which is characterized by an irregular heartbeat, often remains hidden because many people don’t experience symptoms. Atrial fibrillation can increase the risk of stroke and heart failure.
A paper describing the design of this unique clinical trial, the largest screening study on atrial fibrillation ever done, was published online Nov. 1 in the American Heart Journal. Enrollment, which was conducted through an iPhone app, is now closed.
It’s the largest screening study on atrial fibrillation ever doneThe study has entered the final phase of data collection and will be completed early next year, the researchers said. The Stanford team is led by principal investigators Mintu Turakhia, MD, associate professor of cardiovascular medicine, and Marco Perez, MD, assistant professor of cardiovascular medicine, and by study chair Kenneth Mahaffey, MD, professor of cardiovascular medicine. “We hope this study will help us better understand how wearable technologies can inform precision health,” said Lloyd Minor, MD, dean of the School of Medicine. “These new tools, which have the potential to predict, prevent and manage disease, are finally within our reach.” The Food and Drug Administration announced Sept. 11 that it had cleared two mobile medical apps designed by Apple to work on the Apple Watch. One app uses data from new hardware on the Apple Watch Series 4 to take an electrocardiogram by touching the button on the side of the device. The other app uses data from an optical sensor available on the Apple Watch Series 1 and later to analyze pulse data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user. The Apple Heart Study involves only this second app. “The advantage of the app that uses the optical sensor is that it can check for an irregular pulse multiple times throughout the day in the background, without needing the user to actively engage the application,” Perez said.