Home-based Outpatient Multicenter Evaluation Using Electrocardiogram (HOME-ECG)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single-Lead ECG Acquisition [Apple Watch and QOCA ECG102D].
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: 20 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Multicenter Validation of a Home-Based Artificial Intelligence Enabled Single-Lead Electrocardiogram for Detecting Low Ejection Fraction and Structural Heart Disease
Overview
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.
Interventions
- 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.
Primary outcome measures
- Area Under the Receiver Operating Characteristic Curve for Detection of Low Left Ventricular Ejection Fraction [Time frame: 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]
Secondary outcome measures (2)
- Positive Predictive Value and Negative Predictive Value for Structural Heart Disease at the Pre-specified Operating Threshold [Time frame: 30 days]
- Difference in All-Cause Mortality Risk at the Pre-specified Operating Threshold [Time frame: 90 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- Taipei Medical University WanFang Hospital; Far Eastern Memorial Hospital; Taipei Tzu Chi — Taipei
Identifiers
NCT: NCT07488052 · NSTC114-2321-B-016-005