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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
30,000
All 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.
Time frame: 7 days from device application
Rate of newly diagnosed AF (previously undetected)
The proportion of participants in whom new, previously undiagnosed AF is identified through screening.
Time frame: Time Frame: 7 days from device application
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.
Time frame: 6 months post-screening
Major adverse cardiovascular events (MACE)
Composite of all-cause death, ischemic stroke, and hospitalization for heart failure assessed during annual follow-up.
Time frame: Annual follow-up over 10 years
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