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

NCT ID: NCT06847932

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

14726 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-10-01

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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AF-predict AI-ECG alert system

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.

Group Type EXPERIMENTAL

AF-predict AI-ECG alert system guided management

Intervention Type OTHER

AF-predict AI-ECG alert system

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AF-predict AI-ECG alert system guided management

AF-predict AI-ECG alert system

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Days

Maximum Eligible Age

85 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Defense Medical Center, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Chin Lin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chin Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

National Defense Medical Center

Locations

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Tri-Service General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chin Lin, PhD

Role: CONTACT

+886-2-8792-3100 Ext. 18574

ChiaoChin Lee, MD

Role: CONTACT

+886919614672

Facility Contacts

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Yuan-Hao Chen

Role: primary

+886287923311

Other Identifiers

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A202205179

Identifier Type: -

Identifier Source: org_study_id

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