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NCT Number: NCT07488052

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Taipei, 114, Taiwan

Location status: Recruiting

Location contact

CHIN LIN

CONTACT

[email protected]

0958259269

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

CHIN LIN, PhD

CONTACT

[email protected]

+886958259269

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HOME-ECG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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