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Clinical Trials in South Korea / NCT07844434
Starting soon Observational

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

NCT07844434 · tracked via the Priya Life Science South Korea tracker
Sponsor
Inha University Hospital
Phase
Observational
Started
2026-08-30
Last updated
2026-09-28

Condition(s) studied

Heart FailureAtrial Fibrillation (AF)Electrocardiogram

Investigational drug(s) / intervention(s)

SmartECG-EF

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.

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Inha University Hospital Incheon Incheon

More Inha University Hospital trials in South Korea

AI-Powered Electrocardiography for Diagnosis and Prognostic Prediction in Cardiovascular Disease (AI-CVD): Multicenter Retrospective Study Recruiting
AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM Recruiting
Relationship Between Swallowing Dynamics and Suprahyoid Muscle Activity in Sarcopenic Dysphagia Recruiting
Dronedarone Rhythm Intervention for Early Atrial Fibrillation Starting soon
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST) Recruiting

Other trials for the same condition

In-Hospital Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease (INSPIRE) Starting soon
AI-Powered Electrocardiography for Diagnosis and Prognostic Prediction in Cardiovascular Disease (AI-CVD): Multicenter Retrospective Study Recruiting
FENOX Trial (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants) Starting soon
A Research Study Comparing Different Doses of CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy Recruiting
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07844434 on ClinicalTrials.gov ↗ ← All trials in South Korea