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Recruiting Observational

AI ECG Algorithm for Detecting LV Systolic Dysfunction

NCT07636759 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2026-01-01
Last updated
2026-08-07

Condition(s) studied

HF - Heart Failure

Investigational drug(s) / intervention(s)

None-placebo

None-placebo: There is no intervention group

Study summary

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults aged ≥19 years. * Patients who underwent both transthoracic echocardiography and 12-lead electrocardiography (ECG) at Ajou University Hospital in the outpatient, inpatient, or emergency department setting. * ECG and echocardiography performed within 30 days of each other. Exclusion Criteria: * Interval between ECG and echocardiography greater than 30 days. * Missing or corrupted original ECG waveform data (XML or HL7 format). * Presence of an implanted cardiac device, including a permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device. * Missing age, sex, or left ventricular ejection fraction (LVEF) data.

Primary outcome measure(s)

  • AUROC for detection of LVSD (LVEF ≤40%) — During procedure
    Diagnostic performance including AUROC, sensitivity, specificity, positive predictive value, negative predictive value, and accuracy.

Trial sites (1)

FacilityCityRegionStatus
Ajou University School of Medicine Suwon Gyeonggi-do Recruiting
Official registry record

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 NCT07636759 on ClinicalTrials.gov ↗ ← All trials in South Korea