Effectiveness of Artificial IntelliGence-Driven Single-LEad Long-TerM Electrocardiograms MonItoring in Detecting New-Diagnosed Atrial FIbrillation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Age 60 years or older No previous history of atrial fibrillation (AF) Willing to participate in random assignment and follow-up

Locations
Other Locations
China
Beijing Anzhen Hospital
RECRUITING
Zhejiang
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2028-07-30
Participants
Target number of participants: 15360
Treatments
Experimental: Long-term Screening Group
This group will use the 7-day single-lead ECG monitoring device, a standard 12-lead ECG, family-centered AF education and opportunistic screening.
Active_comparator: Standard Screening Group
This group will receive a standard 12-lead ECG, family-centered AF education and opportunistic screening.
Sponsors
Leads: Beijing Anzhen Hospital

This content was sourced from clinicaltrials.gov