A study has enrolled more than 400,000 participants to determine if a smartwatch app can accurately identify atrial fibrillation.
Launched last year, the clinical trial—funded by Apple and conducted in collaboration with Stanford Medicine—is being touted as the largest atrial fibrillation screening study ever undertaken.
“We hope this study will help us better understand how wearable technologies can inform precision health,” says Lloyd Minor, MD, dean of the Stanford University School of Medicine. “These new tools, which have the potential to predict, prevent and manage disease, are finally within our reach.”
In September, the Food and Drug Administration approved two mobile medical apps designed by Apple to work on the Apple Watch. One of the apps, which is being leveraged in Apple’s heart study, uses data from an optical sensor available on the Apple Watch and later analyzes pulse rate data to identify irregular heart rhythms suggestive of atrial fibrillation and to notify the user.
“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,” says Marco Perez, MD, a principal investigator and assistant professor of cardiovascular medicine at Stanford.
Participant in the study are required to have a Series 1, 2 or 3 Apple Watch as well as an iPhone with an app that intermittently checks the heart-rate pulse sensor for measurements of an irregular pulse.
“The Apple Heart Study is a prospective, single-arm study whose overall goal is to evaluate the ability of a smartwatch-based irregular pulse notification algorithm to identify AF (atrial fibrillation and atrial flutter) and guide subsequent clinical evaluation,” according to a paper published online in the American Heart Journal.
The study, which has entered the final phase of data collection, is slated for completion early next year.
“We now have access to high-quality sensors 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,” says Mintu Turakhia, MD, a principal investigator and associate professor of cardiovascular medicine at Stanford. “There’s never really been a study like this done before.”