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Not yet recruiting NCT07627672

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

No phase Interventional Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Single-lead patch ECG recorder.
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • AF Detection Rate [Time frame: 7 days from device application]
Secondary outcome measures (3)
  • Rate of newly diagnosed AF (previously undetected) [Time frame: Time Frame: 7 days from device application]
  • Treatment uptake rate [Time frame: 6 months post-screening]
  • Major adverse cardiovascular events (MACE) [Time frame: Annual follow-up over 10 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07627672 · FINDING-AF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗