An observational study in HF - Heart Failure, sponsored by Ajou University School of Medicine. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Ajou University School of Medicine · Observational
This prospective observational cohort study aims to evaluate the clinical performance of a deep learning-based electrocardiography (ECG) algorithm (DeepECG LVSD) for detecting left ventricular systolic dysfunction (LVSD), defined as left ventricular ejection fraction (LVEF) ≤40%, using transthoracic echocardiography as the reference standard. Approximately 15,000 adult patients undergoing both ECG and echocardiography within 30 days at Ajou University Hospital will be enrolled. Diagnostic performance will be assessed using the area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. Secondary analyses will evaluate the association between AI-predicted LVSD and 30-day clinical outcomes, including all-cause mortality, emergency department visits, and heart failure rehospitalization.
Left ventricular systolic dysfunction (LVSD) is associated with an increased risk of heart failure, hospitalization, and mortality. Although transthoracic echocardiography is the standard method for assessing left ventricular ejection fraction (LVEF), its widespread use as a screening tool is limited by availability, cost, and the need for specialized personnel. Artificial intelligence (AI)-based electrocardiography (ECG) algorithms have emerged as promising tools for identifying patients with reduced LVEF using routinely acquired ECG signals.
DeepECG LVSD is a deep learning-based ECG algorithm developed to detect LVSD (LVEF ≤40%) from standard 12-lead ECG recordings. Previous retrospective validation studies demonstrated high diagnostic performance; however, prospective clinical validation in real-world practice remains limited.
The purpose of this prospective observational cohort study is to evaluate the diagnostic performance and clinical utility of DeepECG LVSD in adult patients undergoing both ECG and transthoracic echocardiography at Ajou University Hospital. Approximately 15,000 patients aged 19 years or older who have undergone ECG and echocardiography within 30 days will be enrolled.
The primary objective is to assess the accuracy of the AI algorithm for detecting LVSD using echocardiographic LVEF as the reference standard. Diagnostic performance will be evaluated using the area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.
Secondary objectives include evaluating the association between AI-predicted LVSD and short-term clinical outcomes, including 30-day all-cause mortality, emergency department visits, and heart failure rehospitalization. Exploratory subgroup analyses will assess algorithm performance according to demographic and clinical characteristics, including age, sex, heart failure status, chronic kidney disease, hypertension, diabetes mellitus, and the interval between ECG and echocardiography.
This study is designed as a minimal-risk observational study and will provide prospective evidence regarding the effectiveness of AI-enabled ECG screening for LVSD in routine clinical practice. Findings from this study may support broader implementation of AI-based ECG tools for the early identification of patients at risk for heart failure and reduced left ventricular systolic function.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Ajou University School of Medicine is the lead sponsor of 173 studies on the registry; 16 are open to participants now.
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Adult patients aged 19 years or older undergoing routine clinical care at Ajou University Hospital who have both transthoracic echocardiography and 12-lead electrocardiography (ECG) performed within 30 days. Participants may be recruited from outpatient clinics, inpatient wards, or the emergency department.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients aged 19 years or older who underwent both transthoracic echocardiography and electrocardiography (ECG) within 30 days of each other
Other: None-placebo
There is no intervention group
AUROC for detection of LVSD (LVEF ≤40%)
Diagnostic performance including AUROC, sensitivity, specificity, positive predictive value, negative predictive value, and accuracy.
Time frame: During procedure
Plan to share: No — Individual participant data will not be publicly shared due to patient privacy and institutional data protection policies.
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