Clinical Trial

External Validation of Artificial Intelligence-enabled Electrocardiography (AI-ECG) for the Detection of Left Ventricular Dysfunction (LVD)

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Record status
This record was last updated June 26, 2025 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a multi-center, retrospective study evaluating the performance of an artificial intelligence-enabled electrocardiography (AI-ECG) algorithm in detecting reduced left ventricular ejection fraction (LVEF ≤ 40%). All included patients from participating hospitals must have undergone a digital 12-lead electrocardiogram (ECG) and an echocardiogram with assessment of LVEF within seven days. The AI-ECG algorithm will be applied to evaluate its diagnostic performance, which will be further assessed across subgroups stratified by demographic characteristics and clinical factors.
Trial Details
NCT Number NCT07038018
Lead Sponsor Tri-Service General Hospital (TSGH)
Conditions Cardiac Disease
Enrollment 12,500 participants
Start Date 2025-08-01
Primary Completion 2025-08-31 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-26