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

National Defense Medical Center, Taiwan

Status: Enrolling

Conditions: Heart Failure

Treatments: Diagnostic Test: Single-Lead ECG Acquisition [Apple Watch and QOCA ECG102D]

Study type: Observational

Funder types: Other

Identifiers

NCT07488052

NSTC114-2321-B-016-005

Details and patient eligibility

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

5,000 participants in 1 patient group

Prospective Validation Cohort

Description:

Adults enrolled at participating hospitals who undergo model-compatible single-lead ECG acquisition and reference transthoracic echocardiography for prospective validation of AI-ECG models for low ejection fraction and structural heart disease.

Treatment:

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