NCT07844434Recruiting
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
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
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 9 Sept 2026
- Start date
- 10 Nov 2026
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- Inha University Hospital
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT07844434
What you commit to
- Study type: Observational
- Planned participants: 300
- From 10 Nov 2026 to the primary completion date, 30 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inha University Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.