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NCT Number: NCT06847932

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

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.

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Key information

Age range

40 day–85 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location status: Recruiting

Location contact

Chin Lin, PhD

PRINCIPAL_INVESTIGATOR

Yuan-Hao Chen

CONTACT

[email protected]

+886287923311

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AF-predict AI-ECG alert system guided management

Other

AF-predict AI-ECG alert system

Primary outcomes

  1. Latent atrial fibrillation

    Time frame: Within 90 days after enrollment.

    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.

Secondary outcomes

  1. Antiarrhythmic treatment

    Time frame: Within 180 days after enrollment.

    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.

  2. 90-days New diagnoses of atrial fibrillation/atrial flutter

    Time frame: Within 90 days after enrollment.

    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.

  3. Atrial arrhythmia with high AF risk

    Time frame: Within 90 days after enrollment.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ChiaoChin Lee, MD

CONTACT

[email protected]

+886919614672

Chin Lin, PhD

CONTACT

[email protected]

+886-2-8792-3100 Ext. 18574

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study title

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

Acronym: LATENT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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