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

NCT06842147 | Recruiting DMC

• 1 other identifier: Beijing An Zhen Hospital
• Study Type: interventional
• Target: 15,360
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

atrial fibrillation; patch

Outcome Measures

Primary Outcomes (2)

• Detection rate of new atrial fibrillation diagnoses

  Detection rate of new atrial fibrillation diagnoses in both groups. Atrial fibrillation is defined by a single-lead ECG (≥30s) or a 12-lead ECG (≥10s) showing absent P waves, replaced by irregular fibrillation waves (f-waves) of varying size, shape, and duration, and absolute irregularity of RR intervals. Two cardiologists will interpret the ECG, and if there is doubt, a third cardiologist will review the case. Opportunistic ECG is defined as any ECG performed for medical reasons during follow-up (primarily 12-lead ECG), which must be reported and diagnosed.

  1 year

• Composite endpoints

  The all-cause mortality, stroke/systemic embolism, and heart failure hospitalization rate in the study population.

  3 years

Secondary Outcomes (7)

• Atrial Fibrillation Burden Assessment

  1 year

• All-Cause Mortality Rate

  3 years

• Cardiovascular Mortality Rate

  3 years

• Stroke/systemic embolism:

  3 years

• Heart Failure Hospitalization Rate

  3 years

Study Arms (2)

Long-term Screening Group

EXPERIMENTAL

This group will use the 7-day single-lead ECG monitoring device, a standard 12-lead ECG, family-centered AF education and opportunistic screening.

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

Standard Screening Group

ACTIVE COMPARATOR

This group will receive a standard 12-lead ECG, family-centered AF education and opportunistic screening.

Device: Standard Screening Group

Interventions

Standard Screening Group DEVICE

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.

Standard Screening Group

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

Long-term Screening Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Zhejiang, Quzhou, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 24, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-12

Locations

CN (1)