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NCT07844434

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

Sponsor: Inha University Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2026-08-30

Completion Date

2028-03-30

Last Updated

2026-09-28

Healthy Volunteers

No

Interventions

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.

Locations (1)

Inha University Hospital

Incheon, Incheon, South Korea