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

National Defense Medical Center, Taiwan

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06847932

A202205179

Details and patient eligibility

About

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.

Enrollment: 14,726 estimated patients

Sex: All

Ages: 40 to 85 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

14,726 participants in 2 patient groups

AF-predict AI-ECG alert system

Experimental group

Description:

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.

Treatment:

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

Standard of care

No Intervention group

Description:

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