iRhythm's Zio Home-Based Monitoring Shows Faster AFib Diagnosis In AMALFI Trial; ESC 2025 And JAMA Publication Highlight Results

Author: Benzinga Newsdesk | August 29, 2025 07:03am

• Oxford University-led AMALFI clinical trial results presented at the European Society of Cardiology (ESC) Congress 2025 and published in the Journal of the American Medical Association (JAMA).
• AMALFI tested whether home-based, self-applied use of iRhythm's Zio long-term continuous monitoring (LTCM) device and service could improve diagnosis of atrial fibrillation (AFib) in 5040 participants in the United Kingdom (UK).
• A remote screening strategy with the Zio LTCM service led to an increase in AFib detection and shorter time to diagnosis versus usual care. Findings confirm efficacy of Zio LTCM service for AFib detection in patients at moderate to high risk of stroke, generalized to a UK population using home-based device application and activation.

SAN FRANCISCO, Aug. 29, 2025 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC) announced results from the Oxford University-led Active Monitoring for AtriaL FIbrillation (AMALFI) randomized clinical trial, presented at the European Society of Cardiology (ESC) Congress 2025 and simultaneously published in the Journal of the American Medical Association (JAMA), demonstrating that home-based screening with the Zio® long-term continuous monitoring (LTCM) service led to increased atrial fibrillation (AFib) detection and a shorter time to diagnosis.

AMALFI was a prospective, parallel group, randomized controlled trial designed to test whether home-based screening for AFib in people aged ≥65 years at moderate to high-risk stroke risk factors, using an on-label Zio XT LTCM device with monitoring up to 14 days, could improve AFib detection compared to usual care over 2.5 years of follow-up. Participants were randomized, half were assigned to wear the Zio LTCM device for 14 days in addition to their usual care, while the other half continued with their usual care and did not receive a monitoring device. The study enrolled 5,040 eligible participants identified via an automated search of electronic records in 27 participating primary care practices in the United Kingdom (UK), and was an entirely remote study, with no physical study sites or in-person visits. Compared to prior screening trials, AMALFI enrolled patients with a higher comorbidity burden: 73% were age ≥75, 19% had a prior stroke or transient ischemic attack, 28% had diabetes, and 18% had chronic kidney disease. Still, in this older population who self-applied the device at home, the median wear time of the Zio LTCM device in the intervention arm was 13.9 days and with a high (98.8%) analyzable time.

At 2.5 years of follow-up, the study found that home-based screening with the Zio LTCM service led to a modestly higher increase in new diagnosis of AFib in 172/2520 (6.8%) participants in the intervention arm vs 136/2520 (5.4%) participants in the control arm (ratio of proportions 1.26, 95% CI 1.02-1.57, p=0.03), and a faster time to diagnosis with AFib recorded at a median of 103 days (IQR 43-539) in the intervention arm vs 530 days (IQR 276-688) in the control arm, using an intention to screen analytic approach. Participants in the intervention arm were more likely to be prescribed oral anticoagulation for stroke prevention, with an average of 1.63 months exposure compared to 1.14 months in the control arm over the study period (difference 0.50 months, 95% CI 0.24-0.75, p<0.001).

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