This prospective, multicenter, single-arm study evaluates the effectiveness of a single-lead patch electrocardiogram (ECG) recorder in screening for atrial fibrillation (AF) among community-dwelling elderly individuals aged ≥60 years in China. Participants will undergo 7 days of continuous ECG monitoring, followed by annual follow-up for up to 10 years to assess long-term outcomes including stroke, heart failure, and death.
Age ≥60 years
No prior diagnosis of atrial fibrillation
Able to understand the study purpose and willing to provide written informed consent
No severe cardiac disease, acute illness, or contraindication to ECG monitoring
Severe cognitive impairment or inability to cooperate with follow-up assessments
Pregnant or breastfeeding women
Previously diagnosed with atrial fibrillation and already receiving treatment
Single group
Single-lead patch ECG recorder
DeviceAll enrolled participants will wear a single-lead patch ECG recorder for 7 consecutive days. The device continuously records cardiac electrical activity, which is wirelessly transmitted to a central database for real-time analysis. AF episodes detected will be reviewed by the clinical team and communicated to the participant's primary care physician for further management.
AF Detection Rate
The proportion of participants in whom atrial fibrillation is detected by the patch ECG recorder during the 7-day monitoring period.
Rate of newly diagnosed AF (previously undetected)
The proportion of participants in whom new, previously undiagnosed AF is identified through screening.
Treatment uptake rate
The proportion of participants with screen-detected AF who receive appropriate treatment (including anticoagulation, antiarrhythmic therapy, or other guideline-recommended interventions) within 6 months of detection.
Major adverse cardiovascular events (MACE)
Composite of all-cause death, ischemic stroke, and hospitalization for heart failure assessed during annual follow-up.
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