AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG

NCT07844434 — Not yet recruiting, 300 participants, Inha University Hospital

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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

Registry	NCT07844434
Status	Not yet recruiting
Study type	Observational
Enrollment	300 (Estimated)
Sponsor	Inha University Hospital (Other)
Conditions	Heart Failure, Atrial Fibrillation (AF), Electrocardiogram
Interventions	SmartECG-EF (Device)
Dates	start 2026-08-30 (estimated), primary completion 2027-08-30 (estimated), completion 2028-03-30 (estimated), first posted 2026-09-28, last updated 2026-09-28
Locations	1 site in South Korea

-Summary

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.

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+Detailed description

This is a prospective, single-center pilot study conducted at Inha University Hospital to evaluate the clinical performance and feasibility of the SmartECG-EF software. Eligible participants will undergo standard clinical evaluations alongside the investigational device assessment. The study aims to investigate the diagnostic utility and operational workflow of integrating the software into routine clinical practice. Data regarding clinical parameters, primary and secondary outcome measures, and any device-related adverse events will be systematically collected and analyzed to assess safety and efficacy.

+Arms and interventions

Arm	Type	Interventions	Description
SmartECG-EF Evaluation Group		Device: SmartECG-EF	Patients undergoing prospective evaluation using the SmartECG-EF software for cardiac function assessment and ECG-based parameter analysis at Inha University Hospital.

SmartECG-EF (Device): The SmartECG-EF software is used to analyze 12-lead and 1-lead electrocardiogram (ECG) data to evaluate cardiac function, including left ventricular systolic dysfunction (LVSD), heart failure indicators, and related arrhythmic parameters.

+Outcome measures

Primary outcomes

Correlation and Agreement between 12-Lead and 1-Lead AI Scores [Day 1]: To evaluate the correlation (using Pearson or Spearman correlation coefficients), agreement (ICC using absolute agreement, two-way random model), and Bland-Altman analysis (mean difference and 95% limits of agreement) between 12-lead and 1-lead based AI scores.

Secondary outcomes

Area Under the ROC Curve (AUC-ROC) of AI scores [Baseline]: To assess the AUC-ROC of 1-lead and 12-lead based AI results against disease-specific reference standards, including heart failure, left ventricular systolic dysfunction (LVSD), and arrhythmic parameters.
Sensitivity and Specificity of AI scores [baseline]: To assess sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 1-lead and 12-lead based AI results against disease-specific reference standards, including heart failure, left ventricular systolic dysfunction (LVSD), and arrhythmic parameters.

+Eligibility

Sex: All, ages: 19 Years to any

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)

+Locations (1)

Facility	City	Country	Status
Inha University Hospital	Incheon, Incheon	South Korea