NCT07488052Recruiting
Home-based Outpatient Multicenter Evaluation Using Electrocardiogram (HOME-ECG)
Prospective Multicenter Validation of a Home-Based Artificial Intelligence Enabled Single-Lead Electrocardiogram for Detecting Low Ejection Fraction and Structural Heart Disease
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 17 Mar 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- National Defense Medical Center, Taiwan
- Diseases
- Heart failure
- NCT number
- NCT07488052
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 1 Mar 2026 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Echocardiography unavailable or technically inadequate for determining left ventricular ejection fraction (EF)
Other
- ECG signal quality insufficient for prespecified AI analysis
- No transthoracic echocardiography available within 30 days after the index ECG
Who the study is looking for
- 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
Age in the registry: 20 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 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 Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.