Effectiveness of Artificial IntelliGence-Driven Single-LEad Long-TerM Electrocardiograms MonItoring in Detecting New-Diagnosed Atrial FIbrillation
Recruiting now · Not applicable
Conditions studied: Atrial Fibrillation (AF)
In brief
Abstract Purpose: Atrial fibrillation (AF) is a leading cause of stroke and heart failure, yet detection remains suboptimal in rural settings due to limited resources. This study evaluates whether an enhanced screening strategy using artificial intelligence (AI)-integrated 7-day single-lead electrocardiogram (ECG) patches improves AF detection and long-term clinical outcomes compared to routine care in rural China. Methods: This cluster-randomized trial will be conducted across 128 village clinics in Quzhou, Zhejiang Province. Villages are randomized 1:1 to either enhanced or routine screening. Participants aged 60 years or older (approximately 120 per village) in both arms receive family-centered AF education and opportunistic assessments. The enhanced group undergoes screening via 7-day single-lead ECG patches, while the routine group utilizes standard 12-lead ECGs. Results: The trial features two primary endpoints. The Phase 1 endpoint is the newly diagnosed AF detection rate during a 1-year screening period. The Phase 2 endpoint is a 3-year composite outcome of all-cause mortality, stroke or systemic embolism, and hospitalization for heart failure. Conclusion: By integrating wearable AI technology into primary care, this trial seeks to overcome diagnostic barriers in resource-limited environments. The findings will determine if prolonged digital monitoring can significantly enhance AF detection and reduce major cardiovascular events in elderly rural populations.
Key facts
- Study ID
- NCT06842147
- Run by
- Beijing Anzhen Hospital
- People needed
- 15360
- Starts
- 2025-03-01
- Expected to finish
- 2028-07-30
- Last updated by the study team
- 2026-01-07
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 60 years or older No previous history of atrial fibrillation (AF) Willing to participate in random assignment and follow-up
You may not qualify if…
- 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 is running
- Beijing Anzhen Hospital — Zhejiang, Quzhou, China (enrolling)
Full record on ClinicalTrials.gov
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