Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-lead patch ECG recorder | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-lead patch ECG recorder | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| AF Detection Rate | The proportion of participants in whom atrial fibrillation is detected by the patch ECG recorder during the 7-day monitoring period. | 7 days from device application |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of newly diagnosed AF (previously undetected) | The proportion of participants in whom new, previously undiagnosed AF is identified through screening. | Time Frame: 7 days from device application |
| Treatment uptake rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song Zuo, MD | Contact | +8618801427775 | song_zuo@126.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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.
| 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. | Annual follow-up over 10 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |