Home-based Outpatient Multicenter Evaluation Using Electrocardiogram (HOME-ECG) (HOME-ECG)

March 21, 2026 updated by: Chin Lin, National Defense Medical Center, Taiwan

Prospective Multicenter Validation of a Home-Based Artificial Intelligence Enabled Single-Lead Electrocardiogram for Detecting Low Ejection Fraction and Structural Heart Disease

This prospective multicenter observational study will validate the accuracy of a previously developed artificial intelligence-enabled single-lead electrocardiogram (AI-ECG) model for identifying low ejection fraction and other structural heart disease phenotypes. Adult participants receiving a model-compatible single-lead electrocardiogram (ECG) (Apple Watch and QOCA ECG102D) and transthoracic echocardiography at five hospitals in Taiwan will be enrolled between March 1, 2026 and June 30, 2026. Model predictions will be compared with echocardiographic reference standards obtained within 30 days after the index ECG.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • Recruiting
        • Taipei Medical University WanFang Hospital; Far Eastern Memorial Hospital; Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation; Chi Mei Medical Hospital; and China Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Consecutive adult participants undergoing model-compatible single-lead ECG acquisition and paired echocardiographic assessment at five participating hospitals (Taipei Medical University WanFang Hospital; Far Eastern Memorial Hospital; Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation; Chi Mei Medical Hospital; and China Medical University Hospital) in Taiwan during the prospective enrollment period.

Description

Inclusion Criteria:

  • Age 20 years or older
  • Single-lead ECG recorded using a study-compatible device
  • Ability to comply with study procedures and, when applicable, provide informed consent according to local institutional review board (IRB) requirements
  • No transthoracic echocardiography performed within 90 days before the index ECG

Exclusion Criteria:

  • ECG signal quality insufficient for prespecified AI analysis
  • No transthoracic echocardiography available within 30 days after the index ECG
  • Echocardiography unavailable or technically inadequate for determining left ventricular ejection fraction (EF)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospective Validation Cohort
Adults enrolled at participating hospitals who undergo model-compatible single-lead ECG acquisition and reference transthoracic echocardiography for prospective validation of AI-ECG models for low ejection fraction and structural heart disease.
Diagnostic test: Single-Lead ECG Acquisition [Apple Watch and QOCA ECG102D]
A single-lead Lead-I ECG recorded using a device compatible with the prespecified AI-ECG pipeline and analyzed offline by the locked AI model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Receiver Operating Characteristic Curve for Detection of Low Left Ventricular Ejection Fraction
Time Frame: 30 days
AUC with 95% confidence interval for detection of low EF, defined as echocardiographic LVEF ≤40%, by the pre-specified AI-enabled single-lead ECG model.
30 days
Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value for Low EF Detection at the Pre-specified Operating Threshold
Time Frame: 30 days
Diagnostic operating characteristics of the locked AI model for low EF at the pre-specified threshold.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Predictive Value and Negative Predictive Value for Structural Heart Disease at the Pre-specified Operating Threshold
Time Frame: 30 days
Prevalence of structural heart disease in patients identified as positive and negative by AI-ECG for detecting low EF, including left atrial enlargement, valvular heart disease, pulmonary hypertension, left ventricular hypertrophy, etc.
30 days
Difference in All-Cause Mortality Risk at the Pre-specified Operating Threshold
Time Frame: 90 days
All-cause mortality risk in patients identified as positive and negative by AI-ECG for detecting low EF.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Defense Medical Center, Taiwan

Collaborators

China Medical University Hospital
Far Eastern Memorial Hospital
Taipei Medical University WanFang Hospital
Chi Mei Medical Hospital
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Investigators

  • Principal Investigator: Chin Lin, PhD, National defense medical center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 21, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSTC114-2321-B-016-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data are not planned for public sharing. Aggregate summary results may be reported in publications and registry updates.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Single-Lead ECG Acquisition [Apple Watch and QOCA ECG102D]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe