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

NCT06842147 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15360

Last updated 2026-01-07

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Fibrillation (AF)

Interventions

DEVICE

7-day single-lead long-term ECG monitoring device.

Participants in the long-term screening group will undergo baseline data collection and a 12-lead ECG at baseline, followed using a 7-day single-lead long-term ECG monitoring device. This device continuously collects dynamic ECG data for seven days and allows participants to view and store ECGs through the accompanying software (registration number: 20192070163).

DEVICE

Standard Screening Group

Patients in the standard screening group will undergo baseline data collection and a standard 12-lead ECG at the start of the study, with follow-up including opportunistic ECG checks as needed. Those diagnosed with AF will receive anticoagulation and antiarrhythmic therapy according to clinical guidelines.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2028-07-30
Completion
2028-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06842147 on ClinicalTrials.gov