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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorToho University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

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

Disqualifiers

Age <18 years

History of long-standing persistent or permanent atrial fibrillation

Frequent premature beats preventing acquisition of a sinus rhythm ECG

Patients with no clinical indication to suspect atrial fibrillation

Trial population

The study will be conducted at 6 centers throughout Japan, with the goal of enrolling a total of approximately 300-350 cases.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

the 1-2-year composite endpoint of all-cause death and major adverse cardiac events (MACE), including AF recurrence

Time frame
one-two year

Secondary outcomes

Other outcomes

Sponsors and contacts

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