TY  - JOUR
AU  - Wouters, Femke
AU  - Gruwez, Henri
AU  - Smeets, Christophe
AU  - Pijalovic, Anessa
AU  - Wilms, Wouter
AU  - Vranken, Julie
AU  - Pieters, Zoë
AU  - Van Herendael, Hugo
AU  - Nuyens, Dieter
AU  - Rivero-Ayerza, Maximo
AU  - Vandervoort, Pieter
AU  - Haemers, Peter
AU  - Pison, Laurent
PY  - 2025
DA  - 2025/1/9
TI  - Comparative Evaluation of Consumer Wearable Devices for Atrial Fibrillation Detection: Validation Study
JO  - JMIR Form Res
SP  - e65139
VL  - 9
KW  - atrial fibrillation
KW  - AF
KW  - mobile health
KW  - photoplethysmography
KW  - electrocardiography
KW  - smartphone
KW  - consumer wearable device
KW  - wearable devices
KW  - detection
KW  - electrocardiogram
KW  - ECG
KW  - mHealth
AB  - Background: Consumer-oriented wearable devices (CWDs) such as smartphones and smartwatches have gained prominence for their ability to detect atrial fibrillation (AF) through proprietary algorithms using electrocardiography or photoplethysmography (PPG)–based digital recordings. Despite numerous individual validation studies, a direct comparison of interdevice performance is lacking. Objective: This study aimed to evaluate and compare the ability of CWDs to distinguish between sinus rhythm and AF. Methods: Patients exhibiting sinus rhythm or AF were enrolled through a cardiology outpatient clinic. The participants were instructed to perform heart rhythm measurements using a handheld 6-lead electrocardiogram (ECG) device (KardiaMobile 6L), a smartwatch-derived single-lead ECG (Apple Watch), and two PPG-based smartphone apps (FibriCheck and Preventicus) in a random sequence, with simultaneous 12-lead reference ECG as the gold standard. Results: A total of 122 participants were included in the study: median age 69 (IQR 61-77) years, 63.9% (n=78) men, 25% (n=30) with AF, 9.8% (n=12) without prior smartphone experience, and 73% (n=89) without experience in using a smartwatch. The sensitivity to detect AF was 100% for all devices. The specificity to detect sinus rhythm was 96.4% (95% CI 89.5%-98.8%) for KardiaMobile 6L, 97.8% (95% CI 91.6%‐99.5%) for Apple Watch, 98.9% (95% CI 92.5%‐99.8%) for FibriCheck, and 97.8% (95% CI 91.5%‐99.4%) for Preventicus (P=.50). Insufficient quality measurements were observed in 10.7% (95% CI 6.3%-17.5%) of cases for both KardiaMobile 6L and Apple Watch, 7.4% (95% CI 3.9%‐13.6%) for FibriCheck, and 14.8% (95% CI 9.5%‐22.2%) for Preventicus (P=.21). Participants preferred Apple Watch over the other devices to monitor their heart rhythm. Conclusions: In this study population, the discrimination between sinus rhythm and AF using CWDs based on ECG or PPG was highly accurate, with no significant variations in performance across the examined devices. Trial Registration: ClinicalTrials.gov NCT06023290; https://clinicaltrials.gov/study/NCT06023290 
SN  - 2561-326X
UR  - https://formative.jmir.org/2025/1/e65139
UR  - https://doi.org/10.2196/65139
DO  - 10.2196/65139
ID  - info:doi/10.2196/65139
ER  -