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

NCT07844434 | Not Yet Recruiting

• 1 other identifier: 2026-03-034-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Atrial Fibrillation (AF); Electrocardiogram

Keywords

Artificial Intelligence; Electrocardiogram; Heart Failure; Left Ventricular Dysfunction; Atrial Fibrillation; Pilot Study

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (2)

• Area Under the ROC Curve (AUC-ROC) of AI scores

  Baseline

• Sensitivity and Specificity of AI scores

  baseline

Study Arms (1)

SmartECG-EF Evaluation Group

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

Interventions

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.

SmartECG-EF Evaluation Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients visiting Inha University Hospital who undergo standard 12-lead and additional 1-lead ECG evaluations for cardiac assessment.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Inha University Hospital: lead

Study Sites (1)

Inha University Hospital

Incheon, Incheon, 22332, South Korea

Location

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventricular Dysfunction

Central Study Contacts

Yongsoo Baek, M.D., Ph.D.

CONTACT

+82-32-890-2200; existsoo@inha.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 28, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

KR (1)