An observational study in Heart Failure, Atrial Fibrillation (AF) and Electrocardiogram, sponsored by Inha University Hospital. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Inha University Hospital · Observational
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.
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.
Patients visiting Inha University Hospital who undergo standard 12-lead and additional 1-lead ECG evaluations for cardiac assessment.
Exclusion Criteria:
Patients undergoing prospective evaluation using the SmartECG-EF software for cardiac function assessment and ECG-based parameter analysis at Inha University Hospital.
Device: SmartECG-EF
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.
Correlation and Agreement between 12-Lead and 1-Lead AI Scores
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.
Time frame: Day 1
Area Under the ROC Curve (AUC-ROC) of AI scores
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.
Time frame: Baseline
Sensitivity and Specificity of AI scores
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.
Time frame: baseline
Plan to share: Undecided — A specific plan for sharing individual participant data has not yet been finalized as this is a pilot study. Data sharing will be evaluated upon reasonable request and in accordance with institutional guidelines and IRB approvals.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Inha University Hospital