AI-driven 7-day single-lead ECG patch monitoring to detect new atrial fibrillation in older adults
Official title: Effectiveness of Artificial IntelliGence-Driven Single-LEad Long-TerM Electrocardiograms MonItoring in Detecting New-Diagnosed Atrial FIbrillation
Run by Beijing Anzhen Hospital · NCT06842147 · Data updated 2026-11-12
This project will test whether AI-read 7-day single-lead ECG patches can find new atrial fibrillation in people aged 60 and older in rural China better than routine 12-lead ECG screening.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 15360 (estimated) |
| Sponsor | Beijing Anzhen Hospital Academic / other |
| Locations | 1 site (Zhejiang, Quzhou) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | July 30, 2028 |
| Study ends | July 30, 2028 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT06842147 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are residents aged 60 or older in participating villages with no prior history of atrial fibrillation who can provide informed consent and complete follow-up.
✕Probably not a fit
Patients with pacemakers/ICDs, significant cognitive impairment, an expected life expectancy under one year, or who cannot wear the patch are unlikely to gain benefit from this screening approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a cluster-randomized trial in 128 village clinics in Qujiang District, Quzhou City, comparing an enhanced screening strategy using AI-integrated 7-day single-lead ECG patches to routine care with standard 12-lead ECGs. Villages are randomized 1:1, and participants aged 60 or older in both arms receive family-centered AF education and opportunistic assessments at local clinics. The co-primary endpoints are the 1-year rate of newly diagnosed AF and a 3-year composite of all-cause death, stroke or systemic embolism, and hospitalization for heart failure. Screening is delivered through village clinics supported by township health centers within the local three-tier healthcare system.
Why it matters
Potential benefit: If successful, the approach could increase AF detection in rural areas and enable earlier treatment to reduce stroke and heart-failure hospitalizations.
How similar studies have gone: Previous studies using single-lead long-term patches and AI algorithms have improved AF detection, though large cluster-randomized evaluations in rural primary-care settings remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Age 60 years or older No previous history of atrial fibrillation (AF) Willing to participate in random assignment and follow-up Exclusion Criteria: Patients with a pacemaker or implanted cardioverter-defibrillator (ICD) Patients with cognitive impairment or unable to provide informed consent Patients with an estimated life expectancy of less than one year (e.g., advanced cancer or end-stage renal disease) Patients deemed unsuitable for the study by the investigator Patients who refuse to participate
Where it's running
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Beijing Anzhen Hospital
Zhejiang, Quzhou, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.