RecruitingNCT07316231

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

Toho Multicenter Registry for Evaluating the Accuracy and Practical Utility of AI-Enhanced 12-Lead ECG in Monitoring Atrial Fibrillation


Sponsor

Toho University

Enrollment

350 participants

Start Date

Sep 11, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria2

  • 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

Exclusion Criteria4

  • 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

Locations(1)

Toho University

Ōta-ku, Tokyo, Japan

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NCT07316231