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NCT07038018

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

Sponsor: Tri-Service General Hospital

View on ClinicalTrials.gov

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.

Official title: External Validation of Artificial Intelligence-Enabled Electrocardiograms for the Detection of Reduced Left Ventricular Ejection Fraction

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

12500

Start Date

2025-08-01

Completion Date

2025-09-30

Last Updated

2025-06-26

Healthy Volunteers

Not specified

Conditions

Interventions

DIAGNOSTIC_TEST

AI-ECG Algorithm

AI-ECG Algorithm to detect LVEF\<=40%

Locations (13)

Hualien Armed Forces General Hospital

Hualien City, Taiwan

Kaohsiung Armed Forces General Hospital Gangshan Branch

Kaohsiung City, Taiwan

Kaohsiung Armed Forces General Hospital

Kaohsiung City, Taiwan

Zuoying Armed Forces General Hospital

Kaohsiung City, Taiwan

Tri-Service General Hospital Keelung Branch

Keelung, Taiwan

Tri-Service General Hospital Penghu Branch

Pengfu, Taiwan

Kaohsiung Armed Forces General Hospital Pingtung Branch

Pingtung City, Taiwan

Taichung Armed Forces General Hospital Zhongqing Branch

Taichung, Taiwan

Taichung Armed Forces General Hospital

Taichung, Taiwan

Tri-Service General Hospital Beitou Branch

Taipei, Taiwan

Tri-Service General Hospital Songshan Branch

Taipei, Taiwan

Taoyuan Armed Forces General Hospital Hsinchu Branch

Taoyuan District, Taiwan

Taoyuan Armed Forces General Hospital

Taoyuan District, Taiwan