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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06847932
• Lead Sponsor: National Defense Medical Center, Taiwan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-21
• Study First Posted: 2025-02-26
• Status Verified: 2025-03
• Study Start: 2025-03-01
• Last Update Submitted: 2025-03-01
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-05-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14726

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Latent atrial fibrillation	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 Outcome Measures

Name	Time	Method
Antiarrhythmic treatment	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.
90-days New diagnoses of atrial fibrillation/atrial flutter	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.
Atrial arrhythmia with high AF risk	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.

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan