Functional And STructural Assesment of the Heart by Artificial Intelligence-enabled Electrocardiogram for the Management of Atrial Fibrillation
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Composite of all-cause Mortality, Stroke, CV Hospitalization, and AAD-Related SAEs — up to 10 years
Evaluation of the effectiveness of the strategy based on a composite endpoint comprising the following clinical events: 1. All-cause mortality; 2. Stroke or systemic thromboembolism; 3. Hospitalization due to worsening heart failure or acute coronary syndrome; 4. Serious adverse events related to antiarrhythmic drug therapy. The endpoint is defined as the time to the first occurrence of any of these components.
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Seoul National University Hospital trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07486739 on ClinicalTrials.gov ↗ ← All trials in South Korea