AI ECG test to spot LV dysfunction in adults
Official title: Prospective Observational Cohort Study of Deep Learning-based ECG Algorithm for Detecting Left Ventricular Systolic Dysfunction
Run by Ajou University School of Medicine · NCT07636759 · Data updated 2026-11-12
A deep learning ECG tool is being tested to see if it can reliably flag left ventricular systolic dysfunction (LVEF ≤40%) in adults who also have an echocardiogram.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Ajou University School of Medicine Academic / other |
| Locations | 1 site (Suwon, Gyeonggi-do) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT07636759 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 19 years and older who had both ECG and echocardiography within 30 days at Ajou University Hospital.
✕Probably not a fit
Patients whose ECGs or echocardiograms do not clearly reflect LV function, or whose data are incomplete, may not benefit from this diagnostic approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort study at Ajou University Hospital evaluating the DeepECG LVSD AI algorithm on standard 12-lead ECGs, using echocardiography as the reference standard. About 15,000 adults who have had both tests within 30 days will be included. Performance metrics will include AUROC, sensitivity, specificity, positive and negative predictive values, and accuracy, with secondary analyses looking at 30-day outcomes such as mortality, ED visits, and readmissions. No therapeutic intervention is being tested; the study observes diagnostic performance and potential clinical associations in real-world practice.
Why it matters
Potential benefit: If successful, the AI ECG tool could help identify LV dysfunction earlier using routine ECG data.
How similar studies have gone: Previous retrospective validations suggested good performance, but prospective real-world validation is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Ajou University School of Medicine
Suwon, Gyeonggi-do, South Korea Recruiting
Study contacts
- Study coordinator: Moonseung Soh, Md
- Email: mssoh7701@gmail.com
- Phone: +82-31-219-5111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.