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

NCT07627672 | Not Yet Recruiting

• 1 other identifier: FINDING-AF
• Study Type: interventional
• Target: 30,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; AF screening; Patch ECG; Wearable ECG; Elderly; Community screening; China; FINDING-AF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of newly diagnosed AF (previously undetected)

  Time Frame: 7 days from device application

• Treatment uptake rate

  6 months post-screening

• Major adverse cardiovascular events (MACE)

  Annual follow-up over 10 years

Study Arms (1)

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.

Device: Single-lead patch ECG recorder

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.

Single-lead patch ECG recorder

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe cognitive impairment or inability to cooperate with follow-up assessments
• Pregnant or breastfeeding women
• Previously diagnosed with atrial fibrillation and already receiving treatment

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Song Zuo, MD

CONTACT

+8618801427775; song_zuo@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2036
• Study Completion (Estimated): September 30, 2036
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share