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

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether an AI-enhanced ECG (heart tracing) can accurately detect atrial fibrillation — an irregular heart rhythm — and whether this tool is practical to use in clinical settings. **You may be eligible if...** - You are 18 or older - You have atrial fibrillation or atrial tachycardia (abnormal fast heart rhythms) and your heart is currently in, or can be confirmed to be in, a normal rhythm at the time of the ECG **You may NOT be eligible if...** - You are under 18 years old - You have long-standing persistent or permanent atrial fibrillation - You have very frequent irregular heartbeats that prevent getting a clean heart tracing - Your doctor does not clinically suspect atrial fibrillation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Toho University

Ōta-ku, Tokyo, Japan

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NCT07316231