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.
Study Type
OBSERVATIONAL
Enrollment
5,000
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.
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
Taipei, Taiwan
RECRUITINGArea 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 days
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 days
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 days
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 days
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