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| Name | Class |
|---|---|
| Taipei Medical University WanFang Hospital | OTHER |
| Far Eastern Memorial Hospital | OTHER |
| Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Validation Cohort | Adults enrolled at participating hospitals who undergo model-compatible single-lead ECG acquisition and reference transthoracic echocardiography for prospective validation of AI-ECG models for low ejection fraction and structural heart disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-Lead ECG Acquisition [Apple Watch and QOCA ECG102D] | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CHIN LIN, PhD | Contact | +886958259269 | xup6fup0629@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| CHIN LIN, PhD | National Defense Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | Recruiting | Taipei | 114 |
De-identified individual participant data are not planned for public sharing. Aggregate summary results may be reported in publications and registry updates.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Chi Mei Medical Hospital |
| OTHER |
| China Medical University Hospital | OTHER |
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| 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. | 90 days |
| Taiwan |
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