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

Leveraging AI-ECG Technology for Early Notification and Tracking of AF Development: a Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF); Electrocardiogram; Premature Atrial Complexes; Atrial Arrhythmias; Artificial Intelligence (AI)
• Intervention / Treatment: Other: AF-predict AI-ECG alert system guided management

• Study Type: Interventional
• Enrollment (Estimated): 14726
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chin Lin, PhD; Phone Number: +886-2-8792-3100 Ext. 18574; Email: xup6fup@mail.ndmctsgh.edu.tw
• Study Contact Backup: Name: ChiaoChin Lee, MD; Phone Number: +886919614672; Email: chiaochinlee@hotmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Recruiting
    • Tri-Service General Hospital
    • Contact: Yuan-Hao Chen; Phone Number: +886287923311; Email: chenyh178@gmail.com
    • Principal Investigator: Chin Lin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AF-predict AI-ECG alert system; 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; AF-predict AI-ECG alert system
No Intervention: Standard of care; Patients will receive the standard care, and their ECGs will not be analyzed by AI-ECG before the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiarrhythmic treatment	Antiarrhythmic treatment may include newly prescribed beta-blockers or non-dihydropyridine calcium channel blockers, class Ia, Ic, and III antiarrhythmic drugs, and catheter ablation. Physicians can determine whether a patient requires antiarrhythmic treatment through clinical practice. The outcome is the rate of initiation of antiarrhythmic treatment.	Within 180 days after enrollment.
90-days New diagnoses of atrial fibrillation/atrial flutter	New diagnoses of atrial fibrillation or atrial flutter are defined as those documented by a 12-lead electrocardiogram or by continuous cardiac rhythm monitoring for ≥ 30 seconds. The result will be presented as the rate of new diagnoses of atrial fibrillation or atrial flutter.	Within 90 days after enrollment.
Atrial arrhythmia with high AF risk	Atrial arrhythmia with high AF risk is defined by the following criteria: premature atrial complexes more than 500 beats in 24 hours as recorded by a continuous cardiac rhythm monitor; burst premature atrial complexes exceeding 20 beats as documented in a continuous cardiac rhythm monitor or a 12-lead electrocardiogram, or documented non-sustained AF/AFL in either a continuous cardiac rhythm monitor or a 12-lead electrocardiogram. The result will be presented as the rate of diagnoses of atrial arrhythmia with high AF risk.	Within 90 days after enrollment.

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan
• Investigators: Principal Investigator: Chin Lin, PhD, National defense medical center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Cardiac Complexes, Premature; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Atrial Premature Complexes
• Other Study ID Numbers: A202205179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No