NCT07488052

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: National Defense Medical Center, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2026-03-23
• Last updated: 2026-03-25

Locations

1 site across 1 country: Taiwan