AI-based cardiac analysis using 12-lead and 1-lead ECG
Official title: Prospective Observational Comparative Pilot Study to Evaluate Performance of an AI-based Cardiac Disease Analysis Algorithm Using Standard 12-lead ECG and Single-lead ECG Data
Run by Inha University Hospital · NCT07844434 · Data updated 2026-11-12
A clinician-facing pilot test to see if SmartECG-EF helps evaluate heart function using both 12-lead and single-lead ECGs in adults with heart conditions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Inha University Hospital Academic / other |
| Locations | 1 site (Incheon, Incheon) |
| Status | Recruiting |
| Started | November 10, 2026 |
| Main results expected | August 30, 2027 |
| Study ends | March 30, 2028 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT07844434 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19 and older undergoing standard 12-lead ECG with sinus rhythm, and who can also participate in a 1-lead ECG measurement during the same visit.
✕Probably not a fit
Patients with atrial fibrillation/flutter at the time of examination, pacing rhythms, or those unable to complete additional ECG measurements may not benefit.
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, single-center pilot study at Inha University Hospital to test the clinical performance and feasibility of the SmartECG-EF software during routine ECG evaluations. Eligible participants will receive standard 12-lead ECGs alongside additional 1-lead measurements to assess how the device influences diagnostic workflow and decision making. Data on cardiac parameters, workflow impact, and any device-related safety events will be collected and analyzed. The study aims to determine whether the software can improve diagnostic accuracy and support patient management in real-world clinical practice.
Why it matters
Potential benefit: If successful, the software could help clinicians interpret ECG data more accurately and efficiently, potentially improving patient management.
How similar studies have gone: Previous studies in AI-assisted ECG analysis have shown promising performance; this study adds a real-world, single-center pilot to further validate utility.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent provided voluntarily by the subject * Age ≥ 19 years * Patients who undergo standard 12-lead ECG measurement during the study period * Subjects with sinus rhythm on ECG at the time of examination * Subjects available for additional 1-lead ECG measurement during the same visit Exclusion Criteria: * Subjects deemed inappropriate or unlikely to comply with the study requirements by the investigator * Patients with atrial fibrillation or atrial flutter on ECG at the time of examination * Patients with pacing rhythm due to a pacemaker * Subjects with severe tremor, uncooperativity, or skin conditions that make 1-lead ECG measurement difficult * Subjects whose additional study measurements would delay standard medical care due to a critical medical condition * Withdrawal of consent or refusal to agree to personal information usage * ECG with sub-standard quality (unanalyzable noise, lead disconnection, etc.; note: unanalyzable rate evaluation can be recorded separately)
Where it's running
-
Inha University Hospital
Incheon, Incheon, South Korea Recruiting
Study contacts
- Study coordinator: Yongsoo Baek, M.D., Ph.D.
- Email: existsoo@inha.ac.kr
- Phone: +82-32-890-2200
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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.