The results of the Active Monitoring for Atrial Fibrillation (AMALFI) trial are published in JAMA (The Journal of the American Medical Association) and were presented today at the European Society of Cardiology Congress 2025.
Atrial fibrillation (AF) is a common but often undiagnosed heart rhythm disorder that substantially increases the risk of stroke and heart failure. Early detection of AF is important because it allows for timely treatment that can reduce stroke risk.
The AMALFI trial tested whether screening for AF using a simple wearable ECG patch could improve AF detection in participants aged 65 and over with known stroke risk factors. It included 5,040 participants. Half were randomly assigned to wear the iRhythm Zio® XT monitor for two weeks in addition to their usual medical care, while the other half continued to receive their usual care without wearing a patch.
Participants were followed for 2.5 years to assess whether the patch resulted in more and earlier AF diagnosis and whether this affected prescription of blood-thinning medication (anticoagulants).
Key findings:
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172 study participants (6.8%) who received a patch were diagnosed with AF compared to 136 (5.4%) of those who received usual medical care only (a modest but statistically significant difference).
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Participants who received a patch were diagnosed with AF earlier (median 103 days versus 530 days in the control group).
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Participants who received a patch were more likely to be prescribed anticoagulants, with an average of 1.63 months’ exposure over the study period, compared to 1.14 months in the control group.
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In over half of the 89 participants whose AF was detected by the patch, it was found on the first day of monitoring.
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In 49 cases (55%) the AF detected by the patch was only present for part of the time (low burden) with under 10% of monitored time spent in AF.
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The observed rate of stroke was similar between groups: 2.7% in the screening group and 2.5% in the control group, but AMALFI was not designed to study direct effects on stroke.
Read the full story on the Nuffield Department of Primary Care Health Sciences website.