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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
AF-predict AI-ECG alert system guided management
Other interventionAF-predict AI-ECG alert system
Treatment groups
Trial 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.
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.
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.
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.
Sponsors and contacts
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