Home-based Outpatient Multicenter Evaluation Using Electrocardiogram (HOME-ECG)
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-90
SponsorNational Defense Medical Center, Taiwan
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Treatments tested in this trial
- Single-Lead ECG Acquisition [Apple Watch and QOCA ECG102D]
Treatment groups
5,000 Participants
are divided into 1 treatment groupSponsors and collaborators
National Defense Medical Center, Taiwan
Lead sponsor
Taipei Medical University WanFang Hospital
Collaborator
Far Eastern Memorial Hospital
Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborator
Chi Mei Medical Hospital
Collaborator
China Medical University Hospital
Collaborator
Source ClinicalTrials.gov