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

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.

Study Overview

• Status: Recruiting
• Conditions: AI-enhanced 12-lead ECG

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Ōta-ku, Tokyo, Japan, 143-8540
      • Recruiting
      • Toho University
      • Contact: Ethics Committee of the Toho University; Phone Number: 81+3-5763-6534; Email: omori.rinri@ext.toho-u.ac.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the 1-2-year composite endpoint of all-cause death and major adverse cardiac events (MACE), including AF recurrence	one-two year

Collaborators and Investigators

• Sponsor: Toho University

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: December 20, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Estimated): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: T2025-051

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No