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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorNational Defense Medical Center, Taiwan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients in the inpatient department or the outpatient department

Patients need to have at least one electrocardiogram within one year

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • AF-predict AI-ECG alert system guided management

    Other intervention

    AF-predict AI-ECG alert system

Treatment groups

14,726 Participants
are divided into 2 treatment groups
Group A: AF-predict AI-ECG alert systemExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

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.
2

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.
3

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.

Other outcomes

Sponsors and contacts

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