A new study will test if Apple’s tool to detect atrial fibrillation can be used to prevent stroke in the long-term. The randomized study, launched on Tuesday by Johnson & Johnson and Apple Inc., will enroll Medicare patients to see if early detection of atrial fibrillation combined with educational tools can reduce the likelihood of stroke and improve health outcomes. The study — called Heartline — is a move by J&J to test the effectiveness of emerging digital health tools.
“Heartline is a study that has the potential to fundamentally change our understanding of how digital health tools, like the ECG app and irregular rhythm notification feature on Apple Watch, could lead to earlier detection of AFib, helping patients understand and directly engage in their heart health, prompting potentially life-saving conversations with their doctors, and improving health outcomes,” Dr. Michael Gibson, co-chair of the Heartline Executive Committee and a professor at Harvard Medical School, said in a news release.
Thousands of Apple Watch wearers have already been using the company’s ECG app to monitor their heart rate. The consumer electronics giant received clearance from the Food and Drug Administration in 2018 for an algorithm meant to detect atrial fibrillation, a common form of irregular heart rhythm that can often go unnoticed.
It has some limitations: the feature is only intended for use by people who have not previously been diagnosed with the condition. A study published on Tuesday also called into question the feature’s accuracy. Conducted by Cleveland Clinic researchers, the study of 50 cardiac surgery patients showed the Apple watch display correctly identified just 41% of instances of atrial fibrillation, but was much more accurate when physicians downloaded a PDF of the results.
Atrial fibrillation can be a significant risk factor for strokes, but up to 30% of patients don’t realize they have the condition until they experience a serious cardiovascular event, such as a stroke, according to a study published in JAMA Cardiology in 2017.
The study will run for three years, enrolling patients 65 and older with Original Medicare and access to an iPhone. All of the trial participants will have access to J&J’s study app, which provides education, tips and questionnaires on heart health. A randomized group of patients will also receive an Apple Watch with the ECG app. Patients will actively participate in the study for two years, followed by one year of data collection.
“Through this important collaboration with Apple, we are pioneering new models that we hope can break down some of the most common barriers to participation in clinical studies,” Dr. Paul Burton, vice president of medical affairs and internal medicine for Janssen Scientific Affairs, said in a news release. “Our work continues to develop and deliver solutions for those impacted by AFib in the areas of detection, treatment and care, through novel approaches, so that we can potentially improve their lives today and well into the future.”
Photo credit: Apple Inc.
