Testing an AI Tool That Reads Heart Tracings to Assess Heart Function
Tests SmartECG-EF software for analyzing heart tracings in people with heart failure or atrial fibrillation.
Plain-language title generated from the registry record
Registry title: AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Key facts
- Where
- Incheon, South KoreaSee the site
Where in South Korea
- Inha University HospitalIncheon, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Inha University Hospital
- Trial code
- NCT07844434
- Record updated
- 30 October 2026
- Original description
This pilot study is designed to evaluate the clinical performance and utility of the SmartECG-EF software in patients undergoing evaluations at Inha University Hospital. The primary objective is to assess how effectively the device assists clinicians in evaluating cardiac function and related clinical parameters. The study will prospectively enroll eligible participants to gather real-world clinical data, contributing to enhanced diagnostic accuracy and patient management.Read full original descriptionShow less
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
This pilot study is designed to evaluate the clinical performance and utility of the SmartECG-EF software in patients undergoing evaluations at Inha University Hospital. The primary objective is to assess how effectively the device assists clinicians in evaluating cardiac function and related clinical parameters. The study will prospectively enroll eligible participants to gather real-world clinical data, contributing to enhanced diagnostic accuracy and patient management.
Inclusion: 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: 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; 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; 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).