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

NCT07316231 | Recruiting

• 1 other identifier: T2025-051
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AI-enhanced 12-lead ECG

Outcome Measures

Primary Outcomes (1)

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

  one-two year

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Toho University: lead

Study Sites (1)

Toho University

Ōta-ku, Tokyo, 143-8540, Japan

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 5, 2026
• Study Start: September 11, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

JP (1)