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Clinical Trials/NCT07627672
NCT07627672Not yet recruitingNot Applicable

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

Beijing Anzhen Hospital0 sites30,000 target enrollmentStarted: September 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
30,000

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
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

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

Investigators

Sponsor
Beijing Anzhen Hospital
Sponsor Class
Other
Responsible Party
Sponsor

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