Clinical trial Recruiting at 1 site Interventional Ages 60 and up

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.

More Atrial Fibrillation (AF) trials

Quick facts

Study typeInterventional
Ages60 Years and up
SexAll
Enrollment15360 (estimated)
SponsorBeijing Anzhen Hospital
Academic / other
Locations1 site (Zhejiang, Quzhou)
StatusRecruiting
StartedMarch 1, 2025
Main results expectedJuly 30, 2028
Study endsJuly 30, 2028
Registry record updatedJanuary 7, 2026
Trial IDNCT06842147 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

  • Beijing Anzhen Hospital
    Zhejiang, Quzhou, China
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.