J&J's Apple Watch-based atrial fibrillation study recruits patients


Apple and Johnson & Johnson have begun enrolling patients in a study that will investigate whether the Apple Watches could be used to detect early signs of atrial fibrillation (AFib).

The tech firm has joined with Johnson & Johnson to answer that question, testing the electrocardiogram (ECG) technology that is already embedded in Apple Watches.

J&J’s Janssen unit has announced the Heartline Study, which involves iPhone and Apple Watch users aged over 65.

Those taking part in the two-year study must also be US resident, and own an iPhone 6s or later, and must be enrolled on the state-backed Medicare plan for older people.

The study was first announced last year and is being run by Michael Gibson, CEO of the Baim Institute for Clinical Research and founder of the Perfuse Study Group at Harvard Medical School.

Gibson, who has studied cardiology for 38 years has joined with cardiologist John Spertus, Daniel J. Lauer/Missouri Endowed Chair in Metabolic and Vascular Disease Research at the University of Missouri–Kansas City, who is study co-lead.

Those on the study will participate in health surveys and other activities in the dedicated Heartline app.

They will receive points for the time and effort spent completing the activities. Depending on the study group patients are assigned to, these points may be redeemed for $150 or more in monetary awards.

Apple currently has FDA clearance for monitoring with its latest Apple Watch, so long as it isn’t used to replace traditional methods of diagnosis or treatment, but the link-up with J&J could give it a clinical pathway to seek an approved health claim in AFib, including stroke prevention.

While AFib typically causes warning symptoms such as dizziness and shortness of breath in around a third of cases it can go undiagnosed, putting people at risk of life-threatening complications such as a stroke. Having AFib gives a four- to five-fold increased risk of stroke, and it kills around 130,000 people in the US every year.

Apple has competitors in the market for its EC-enabled Watch, including Withings which unveiled its MOVE ECG sensor at last year’s Consumer Electronics Show in Las Vegas, and AliveCor, which has an ECG system that has six leads to provide more accuracy.