Johnson & Johnson (J&J) and Apple on Tuesday announced they're teaming up to conduct the largest randomized controlled trial on cardiovascular disease ever in order to determine whether the Apple Watch can detect atrial fibrillation (AFib) among seniors.

Background

AFib is a heart condition that can increase the risk of stroke. It's estimated to affect about 2.7 million Americans and 34 million people around the globe. People with AFib do not always show symptoms, which can make it difficult to diagnose.

In September 2018, Apple revealed its Apple Watch Series 4, which features an FDA-approved electrocardiogram (EKG). A typical EKG is conducted in a doctor's office or hospital and requires attaching electrodes to a patient's chest. But Apple's EKG app requires only a simple press—and 30-second hold—of a button on the watch, after which it informs a user if their heart rhythm is normal or if they are experiencing atrial fibrillation. The data, which Apple says is encrypted, is then stored in the iPhone's Health app, where users can access it and create PDFs to share with their physicians.

Details on the partnership

With the new trial, Apple and J&J want to see if the watch can help catch cases of AFib early and lower the risk of stroke. 

For the trial, the companies will recruit at least 150,000 seniors, who will be randomly assigned to use either an iPhone app called Heartline, which gives them health education and tips, or an Apple Watch in addition to the Heartline app. Researchers will monitor participants to see how accurately the Apple Watch can detect AFib and whether the Heartline app is effective at encouraging patients to take their medications.

The study is open to individuals who are at least 65 years old, enrolled in traditional Medicare, and have an iPhone 6s or newer model with iOS 12.2 or more recent software. Participants who are assigned to the Apple Watch group can buy the watch at a discount or "rent" the watch for free for the duration of the trial.

Best Buy is also involved in the trial. According to Paul Burton, VP of medical affairs for J&J, seniors who are assigned a watch for the trial can pick it up or have it sent from Best Buy. Customer service representatives are available to help participants set up the watches, and participants can also get help at the store. 

Individuals who already have an Apple Watch may join the trial, but certain restrictions apply, the researchers said. 

The companies said that the study could take three years to publish, given its size, and they cautioned that the study may not be successful as there are still some unknowns to explore. Either way, however, the companies will publish the study's results, according Burton.

"Heartline could go down as a landmark clinical trial," Burton said. "We are bringing amazing digital wearable tech and engagement apps for health care to patients and doctors."

Some experts concerned about the app

Some experts have expressed concerns that the Apple Watch's ability to screen for AFib may not be particularly helpful.

Around the time the Apple Watch launched its EKG feature, Aaron Carroll, a professor of pediatrics at Indiana University, in the New York Times' "The Upshot" noted that there are already a number of effective ways to screen for AFib, including blood pressure monitors and even simply taking a pulse during a routine checkup.

He wrote that, if providers believed "detecting asymptomatic people who might have atrial fibrillation" was important enough, "we could screen everyone with electrocardiograms."

The U.S. Preventive Services Task Force considered doing exactly that for adults ages 65 and older but ultimately decided there wasn't enough evidence that it would be better than the current level of care to recommend the practice.

There's also the concern that the watch could lead to false positives and misdiagnosis, Carroll said. "Patients at high risk of stroke who have atrial fibrillation (i.e. older people) might be treated with anticoagulation. For younger ones at lower risk, it's not immediately clear how we would treat them, or if we should," Carroll wrote. "And it's younger people who are more likely to have a smart watch."

However, Jeffrey Wessler, a cardiologist in New York, praised Apple's approach with the new Heartline study specifically focusing on seniors, saying the study "represents an important step forward for the clinical utility of consumer-grade wearables."

He added, "Apple can move beyond the dubious effects of broad based screening and actually demonstrate the effectiveness of a watch-based intervention to improve clinical outcomes" (Farr, CNBC, 2/25; Haselton, CNBC, 2/25; La Monica, CNN, 2/25; Carroll, "The Upshot," New York Times, 12/26/19).