Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT07316231

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

Led by Toho University · Updated on 2026-01-07

350

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patients with atrial fibrillation or atrial tachycardia who maintain or can confirm sinus rhythm during ECG recording
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • History of long-standing persistent or permanent atrial fibrillation
  • Frequent premature beats preventing sinus rhythm ECG acquisition
  • No clinical indication to suspect atrial fibrillation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Toho University

Ōta-ku, Tokyo, Japan, 143-8540

Actively Recruiting

Loading map...

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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