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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

AF Detection Rate

Time frame: 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 outcomes

Rate of newly diagnosed AF (previously undetected)

Time frame: Time Frame: 7 days from device application

The proportion of participants in whom new, previously undiagnosed AF is identified through screening.
Treatment uptake rate

Time frame: 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)

Time frame: Annual follow-up over 10 years

Composite of all-cause death, ischemic stroke, and hospitalization for heart failure assessed during annual follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Song Zuo, MD

CONTACT

[email protected]

+8618801427775

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

Effectiveness of Patch-Electrocardiogram Recorders in Screening for Atrial Fibrillation in Elderly People in the Chinese Community: A Prospective Multicenter Study

Important dates

Study start: 2026
Primary completion: 2036
Study completion: 2036
First posted: Jun 4, 2026
Registry last updated: Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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