Effectiveness of Patch-Electrocardiogram Recorders in Screening for Atrial Fibrillation in Elderly People in the Chinese Community

Sponsor
Beijing Anzhen Hospital
Study ID
NCT07627672
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jun 4, 2026
Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Sep 1, 2036
Completion
Sep 30, 2036

Study Design

Enrollment
30,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Single-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.

Primary Outcome Measure

AF Detection Rate [ Time Frame: 7 days from device application ]

Central Contacts

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