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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06847932
Acronym
LATENT
Enrollment
14726
Registered
2025-02-26
Start date
2025-07-01
Completion date
2026-10-01
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERAF-predict AI-ECG alert system guided management

AF-predict AI-ECG alert system

Sponsors

National Defense Medical Center, Taiwan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Days to 85 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Latent atrial fibrillationWithin 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

MeasureTime frameDescription
Antiarrhythmic treatmentWithin 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.
90-days New diagnoses of atrial fibrillation/atrial flutterWithin 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.
Atrial arrhythmia with high AF riskWithin 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.

Countries

Taiwan

Contacts

Primary ContactChin Lin, PhD
xup6fup@mail.ndmctsgh.edu.tw+886-2-8792-3100 Ext. 18574
Backup ContactChiaoChin Lee, MD
chiaochinlee@hotmail.com+886919614672

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026