As more research continues to emerge regarding the Apple Watch’s EKG feature, the device is gaining credibility in the field of cardiology. Several of these studies have focused on the Apple Watch’s ability to detect atrial fibrillation (AFib), or irregular beating of the heart’s top two chambers known as the atria. The device was found to be over 98% accurate in detecting AFib or other that Apple submitted to the FDA, providing evidence that it is on par with other EKGs.
Though these results suggest the efficacy of the device’s EKG, they do not address the real-world implications of the watch’s use. To analyze this, the National Evaluation System for health Technology Coordinating Center (NESTcc), has launched a Test-Case involving Apple Watch use in AFib patients. This study is among 11 other Test-Cases funded by the NESTcc to evaluate medical devices through real-world data.
Led by Dr. Sanket Dhruva, MD, MHS Assistant Professor at the UCSF School of Medicine, this randomized controlled trial will aim to enroll 150 AFib patients receiving electric cardioversion from Yale-New Haven Hospital, Duke University Hospital, and the Mayo Clinic. This procedure is used to treat AFib by administering an electric shock to the patient’s heart while they are sedated, with the goal of disrupting the abnormal electrical activity in the heart to reset the normal beating rhythm.
Prior to electric cardioversion, these patients will be randomly assigned to either receive an Apple Watch for data collection or to undergo conventional follow-up care, with both groups being monitored for six months after cardioversion. The watch will function to continually measure their cardiac data and patients will also be sent mobile questionnaires to assess their quality of life. Dhruva also noted that the study will analyze whether these patients receive additional testing or treatment for AFib, emergency department and outpatient care, and track blood thinner use as well.
“The research question really is what is the impact of the Apple Watch on people, these patient-reported outcomes–quality of life, symptoms, and also differences in clinical utilization over time,” said Dhruva in an interview with DocWire News. “This is helping us understand the effect of the monitoring that the Apple Watch provides.”
Rather than being prescribed to share all Apple Watch data with their doctors, participants will simply wear the watch for the duration of the trial. The researchers hypothesize that the participants will share data with their physicians similarly to how they would in the real world.
“Imagine a patient purchases an Apple Watch and uses it for his or her own purposes. That’s what we’re trying to emulate,” Dhruva said. “When you give people Apple Watch and when they wear it […] what’s the real-world impact?”
With funding for this project being obtained as recently as weeks ago, Dhruva stated that the team is hoping to begin their work within the coming months. After accounting for the time needed to recruit and monitor participants, he feels that results will likely emerge in 2020.
“There’s a lot of innovation in healthcare technologies these days, and we’re very glad and appreciative that NEST is supporting an evaluation to better understand how these technologies are used,” he said.
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About the NESTcc
The NESTcc is an initiative of the Medical Device Innovation Consortium (MDIC). The U.S. Food and Drug Administration (FDA) awarded the MDIC $3 million in seed funding to establish the NESTcc in 2016. The Coordinating Center functions to facilitate the generation of real-world evidence regarding medical devices.
For more information, visit http://nestcc.org.
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