Home-based Outpatient Multicenter Evaluation Using Electrocardiogram (HOME-ECG)
Recruiting · NCT07488052 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Defense Medical Center, Taiwan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
Where it is running
1 location listed.
- 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, Taiwan