Evaluating the Accuracy and Practical Utility of AI-Enhanced 12-Lead ECG

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

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-11

Study Completion Date

2028-08-31

Brief Summary

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Atrial fibrillation (AF) is a major cause of heart failure and ischemic stroke, making early detection and intervention critically important. However, timely ECG recording during paroxysmal episodes is often difficult, leading to delayed diagnosis. Recently, an AI-enhanced 12-lead ECG equipped with a "hidden AF risk estimation" function has been introduced. This technology analyzes sinus rhythm ECGs and stratifies the likelihood of prior AF into four risk categories. Although this novel approach may facilitate earlier AF detection and optimize the timing of therapeutic intervention, its clinical accuracy and real-world utility remain insufficiently validated. Therefore, this multicenter study aims to evaluate the diagnostic performance and clinical usefulness of AI-based AF risk assessment and to clarify its association with subsequent AF incidence and patient outcomes.

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Detailed Description

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Conditions

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AI-enhanced 12-lead ECG

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years
2. Patients with atrial fibrillation or atrial tachycardia (AF/AT) in whom sinus rhythm is maintained or can be confirmed at the time of ECG recording

Exclusion Criteria

1. Age \<18 years
2. History of long-standing persistent or permanent atrial fibrillation
3. Frequent premature beats preventing acquisition of a sinus rhythm ECG
4. Patients with no clinical indication to suspect atrial fibrillation

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No