Clinical Trial

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

Study acronym: HOME-ECG

Recruiting

Record status

This record was last updated March 25, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2026-03-17.

Trial Details

NCT Number	NCT07488052
Lead Sponsor	National Defense Medical Center, Taiwan Collaborators: Taipei Medical University WanFang Hospital, Far Eastern Memorial Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chi Mei Medical Hospital, China Medical University Hospital
Conditions	Heart Failure
Enrollment	5,000 participants
Start Date	2026-03-01
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-25