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AMALFI Randomized Clinical Trial Results Demonstrate Increased Atrial Fibrillation Diagnosis with Home-Based Long-Term Continuous ECG Monitoring Using iRhythm Technologies’ Zio LTCM Service
Globenewswire· 2025-08-29 11:00
Core Insights - iRhythm Technologies, Inc. announced positive results from the AMALFI clinical trial, indicating that home-based screening with the Zio long-term continuous monitoring (LTCM) service significantly improved atrial fibrillation (AFib) detection and reduced time to diagnosis [1][5][6] Study Design and Population - The AMALFI trial was a randomized controlled trial involving 5,040 participants aged 65 and older with moderate to high stroke risk, comparing home-based screening using the Zio XT LTCM device to usual care over a follow-up period of 2.5 years [2][5] - Participants were identified through an automated search of electronic health records in 27 primary care practices in the UK, and the study was conducted entirely remotely without physical sites [2][6] Key Findings - The intervention group showed a higher rate of new AFib diagnoses (6.8%) compared to the control group (5.4%), with a statistically significant difference (p=0.03) [3][4] - The median time to diagnosis for the intervention group was 103 days, significantly shorter than the 530 days for the control group [3][4] - Participants in the intervention group had a longer average exposure to oral anticoagulation (1.63 months) compared to the control group (1.14 months), indicating improved treatment initiation [3] Implications for Healthcare - The study supports the feasibility of primary care-initiated, home-based diagnostic monitoring, aligning with the NHS's focus on disease prevention and early detection [4][6] - The findings suggest that the Zio LTCM service can be effectively implemented at scale, enhancing the identification of undiagnosed arrhythmias and enabling timely therapeutic interventions [7][8] Technology and Methodology - The Zio LTCM service utilizes a wearable ECG patch that captures continuous data for up to 14 days, processed by a deep-learned algorithm to detect various arrhythmias [6][7] - The service has been available in the US since 2008 and was introduced in the UK in 2014, demonstrating a commitment to improving patient outcomes through innovative technology [6][14]