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
This trial accepts healthy volunteersQualifiers
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 population
Consecutive adult participants undergoing model-compatible single-lead ECG acquisition and paired echocardiographic assessment at five participating hospitals (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) in Taiwan during the prospective enrollment period.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Single-Lead ECG Acquisition [Apple Watch and QOCA ECG102D]
Diagnostic testA single-lead Lead-I ECG recorded using a device compatible with the prespecified AI-ECG pipeline and analyzed offline by the locked AI model.
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: Prospective Validation Cohort1 intervention
Trial outcomes
Primary outcomes
1
Area Under the Receiver Operating Characteristic Curve for Detection of Low Left Ventricular Ejection Fraction
AUC with 95% confidence interval for detection of low EF, defined as echocardiographic LVEF ≤40%, by the pre-specified AI-enabled single-lead ECG model.
Time frame
30 days2
Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value for Low EF Detection at the Pre-specified Operating Threshold
Diagnostic operating characteristics of the locked AI model for low EF at the pre-specified threshold.
Time frame
30 daysSecondary outcomes
1
Positive Predictive Value and Negative Predictive Value for Structural Heart Disease at the Pre-specified Operating Threshold
Prevalence of structural heart disease in patients identified as positive and negative by AI-ECG for detecting low EF, including left atrial enlargement, valvular heart disease, pulmonary hypertension, left ventricular hypertrophy, etc.
Time frame
30 days2
Difference in All-Cause Mortality Risk at the Pre-specified Operating Threshold
All-cause mortality risk in patients identified as positive and negative by AI-ECG for detecting low EF.
Time frame
90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
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