Heart FailureNCT07844434
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
An observational study of Heart Failure and Atrial Fibrillation (AF), run by Inha University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure, Atrial Fibrillation (AF), Electrocardiogram
- What is being tested?
- SmartECG-EF
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2026to 30 Mar 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients visiting Inha University Hospital who undergo standard 12-lead and additional 1-lead ECG evaluations for cardiac assessment.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Inha University Hospital
Incheon, Incheon, 22332
Yongsoo Baek, M.D., Ph.D., +82-32-890-2200, existsoo@inha.ac.kr
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, Atrial Fibrillation (AF), Electrocardiogram
- Being tested
- SmartECG-EF
- Keywords
- Artificial Intelligence, Electrocardiogram, Heart Failure, Left Ventricular Dysfunction, Atrial Fibrillation, Pilot Study
- Medical subject headings
- Heart Failure, Atrial Fibrillation, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartECG-EFDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SmartECG-EF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-Soo Baek, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844434
- Sponsor's protocol ID
- 2026-03-034-001
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.