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Home-based Outpatient Multicenter Evaluation Using Electrocardiogram (HOME-ECG)
Sponsor: National Defense Medical Center, Taiwan
Summary
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.
Official title: Prospective Multicenter Validation of a Home-Based Artificial Intelligence Enabled Single-Lead Electrocardiogram for Detecting Low Ejection Fraction and Structural Heart Disease
Key Details
Gender
All
Age Range
20 Years - 90 Years
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2026-03-01
Completion Date
2026-09-30
Last Updated
2026-03-25
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
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