Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation; AF screening; Patch ECG; Wearable ECG; Elderly; Community screening; China; FINDING-AF
Brief summary
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.
Interventions
DEVICESingle-lead patch ECG recorder
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.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 * Able to wear the patch ECG device and comply with continuous monitoring requirements
Exclusion criteria
* Severe cognitive impairment or inability to cooperate with follow-up assessments * Pregnant or breastfeeding women * Previously diagnosed with atrial fibrillation and already receiving treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AF Detection Rate | 7 days from device application | The proportion of participants in whom atrial fibrillation is detected by the patch ECG recorder during the 7-day monitoring period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of newly diagnosed AF (previously undetected) | Time Frame: 7 days from device application | The proportion of participants in whom new, previously undiagnosed AF is identified through screening. |
| Treatment uptake rate | 6 months post-screening | 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) | Annual follow-up over 10 years | Composite of all-cause death, ischemic stroke, and hospitalization for heart failure assessed during annual follow-up. |
Contacts
CONTACTSong Zuo, MD
Outcome results
None listed