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

National Defense Medical Center, Taiwan14,726 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

14,726

Conditions

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

Eligibility

Sex: ALLMin age: 40 DaysMax age: 85 Days

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Within 90 days after enrollment.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Within 90 days after enrollment.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts