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NOT YET RECRUITING
NCT07486739
NA

Functional And STructural Assesment of the Heart by Artificial Intelligence-enabled Electrocardiogram for the Management of Atrial Fibrillation

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate whether an AI-ECG based screening strategy for detecting cardiac functional and structural abnormalities preserves clinical effectiveness and safety, compared with a conventional strategy of routine echocardiography in patients with AF, thereby demonstrating the non-inferiority of AI-ECG guided care.

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1724

Start Date

2026-07-29

Completion Date

2030-12-31

Last Updated

2026-07-23

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Artificial intelligence-enabled electrocardiography

An artificial intelligence algorithm applied to standard 12-lead electrocardiography designed to predict cardiac structural or functional abnormalities. This tool guides the decision to perform or withhold downstream echocardiography.

DIAGNOSTIC_TEST

Transthoracic Echocardiography-Guided Assessment

Standard Transthoracic Echocardiography used to assess cardiac structure and function, serving as the reference standard for guiding clinical management in this study arm.

Locations (28)

Korea University Ansan Hospital

Ansan, South Korea

Hallym University Sacred Heart Hospital

Anyang, South Korea

Dong-A University Hospital

Busan, South Korea

Samsung Changwon Hospital

Changwon, South Korea

Dankook University Hospital

Cheonan, South Korea

Daegu Catholic University Medical Center

Daegu, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Jeonbuk National University Hospital

Jeonju, South Korea

Presbyterian Medical Center (Jesus Hospital)

Jeonju, South Korea

CHA Bundang Medical Center

Seongnam, South Korea

Asan Medical Center

Seoul, South Korea

Boramae Medical Center

Seoul, South Korea

Eunpyeong St. Mary's Hospital

Seoul, South Korea

Ewha Womans University Seoul Hospital

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Hanyang University Hospital

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Kyung Hee University Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea