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Not yet recruitingNCT07627672Updated Jun 4, 2026

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

An interventional study of Single-lead patch ECG recorder in Atrial Fibrillation, sponsored by Beijing Anzhen Hospital. Not yet recruiting. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
30,000
Allocation
Not applicable
Ages
60 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Atrial Fibrillation

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Keywords

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

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 30,000 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Beijing Anzhen Hospital is the lead sponsor of 188 studies on the registry; 100 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30,000 participants (estimated)

Study 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.

    Device: Single-lead patch ECG recorder

Interventions

  • DeviceSingle-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.

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What researchers measure

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.

    Time frame: 7 days from device application

Secondary outcomes

  1. Rate of newly diagnosed AF (previously undetected)

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

    Time frame: Time Frame: 7 days from device application

  2. 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.

    Time frame: 6 months post-screening

  3. Major adverse cardiovascular events (MACE)

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

    Time frame: Annual follow-up over 10 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07627672
Lead sponsor
Beijing Anzhen Hospital
Responsible party
Sponsor
First posted
Jun 4, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2036 (estimated)
Completion
Sep 30, 2036 (estimated)
Last update
Jun 4, 2026

Study contacts

Song Zuo, MD
Contact
song_zuo@126.com
+8618801427775

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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