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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Single-lead patch ECG recorder

• Study Type: Interventional
• Enrollment (Estimated): 30000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Song Zuo, MD; Phone Number: +8618801427775; Email: song_zuo@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2036
• Study Completion (Estimated): September 30, 2036

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: May 31, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Atrial fibrillation; AF screening; Patch ECG; Wearable ECG; Elderly; Community screening; China; FINDING-AF
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: FINDING-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No