Leveraging AI-ECG Technology for Early Notification and Tracking of AF Development

NCT06847932 | Recruiting

• 1 other identifier: A202205179
• Study Type: interventional
• Target: 14,726
• Locations: 1 country
• Sites: 1

Brief Summary

Our study aimed to use an AF-predict AI-ECG alert system to help physicians identify patients who need to wear a continuous cardiac rhythm monitor for new diagnoses of atrial fibrillation (AF), atrial flutter (AFL), or atrial arrhythmia with high AF risk, including premature atrial complexes (PAC) ≥ 500/24hr, burst PACs \> 20 beats, non-sustained AF/AFL.

Conditions

Atrial Fibrillation (AF); Premature Atrial Complexes; Atrial Arrhythmias; Artificial Intelligence (AI); Electrocardiogram

Outcome Measures

Primary Outcomes (1)

• Latent atrial fibrillation

  The primary outcome, latent atrial fibrillation, is a composite of new diagnoses of AF/AFL, atrial arrhythmia with high AF risk, including PACs ≥ 500/24hr, burst PACs \> 20 beats, and non-sustained AF/AFL, within 90 days after enrollment. The results will be demonstrated as the rate of diagnoses of latent atrial fibrillation.

  Within 90 days after enrollment.

Secondary Outcomes (3)

• Antiarrhythmic treatment

  Within 180 days after enrollment.

• 90-days New diagnoses of atrial fibrillation/atrial flutter

  Within 90 days after enrollment.

• Atrial arrhythmia with high AF risk

  Within 90 days after enrollment.

Study Arms (2)

AF-predict AI-ECG alert system

EXPERIMENTAL

All the patients' ECGs will receive AF-predict AI-ECG analysis. According to the AI-ECG analysis results, those with at least one high-risk ECG within one year will be called back and asked to undergo a continuous cardiac rhythm monitor for up to 7 days. Otherwise, the physicians can review the AI-ECG analysis results for all the patients in the intervention group.

Other: AF-predict AI-ECG alert system guided management

Standard of care

NO INTERVENTION

Patients will receive the standard care, and their ECGs will not be analyzed by AI-ECG before the end of the study.

Interventions

AF-predict AI-ECG alert system guided management OTHER

AF-predict AI-ECG alert system

AF-predict AI-ECG alert system

Eligibility Criteria

• Age: 40 Days - 85 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients in the inpatient department or the outpatient department
• Patients need to have at least one electrocardiogram within one year

You may not qualify if:

• Diagnosis of atrial fibrillation/atrial flutter
• History of atrial fibrillation/atrial flutter catheter ablation
• Patients with cardiac implantable electronic devices
• Any documented electrocardiogram showed atrial fibrillation/atrial flutter and pacing rhythm
• History of received rhythm control medications for atrial arrhythmia, including Class I and Class III antiarrhythmic drugs
• Any reasons indicate for anti-coagulant agents, including vitamin K antagonist and non-vitamin K antagonist oral anticoagulant

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Premature Complexes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature; Cardiac Conduction System Disease

Study Officials

• Chin Lin, PhD

  National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin Lin, PhD

CONTACT

+886-2-8792-3100 Ext. 18574; xup6fup@mail.ndmctsgh.edu.tw

ChiaoChin Lee, MD

CONTACT

+886919614672; chiaochinlee@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)