Home-based heart check using single-lead ECG
Prospective Multicenter Validation of a Home-Based Artificial Intelligence Enabled Single-Lead Electrocardiogram for Detecting Low Ejection Fraction and Structural Heart Disease
This project will test whether an AI algorithm applied to single-lead ECGs from Apple Watch or QOCA devices can detect low ejection fraction and other structural heart problems in adults who also receive an echocardiogram.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | National Defense Medical Center, Taiwan Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07488052 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter observational project will enroll adults at five hospitals in Taiwan who have a compatible single-lead ECG (Apple Watch or QOCA ECG102D) and a transthoracic echocardiogram performed within 30 days. The AI-ECG model's predictions from the single-lead recordings will be compared to echocardiographic reference standards for left ventricular ejection fraction and other structural phenotypes. Participants will be recruited between March 1 and June 30, 2026, and recordings with insufficient signal quality or without timely echocardiography will be excluded. The goal is to validate model accuracy in a real-world, home-based outpatient setting across multiple centers.
Who should consider this trial
Good fit: Adults aged 20 or older who can provide a single-lead ECG with a study-compatible device and will have a transthoracic echocardiogram within 30 days are ideal candidates.
Not a fit: Patients without a compatible device, with poor-quality ECG recordings, or who cannot obtain an echocardiogram within 30 days are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, this approach could enable easier and earlier detection of reduced ejection fraction using wearable ECG devices, leading to quicker follow-up and treatment.
How similar studies have performed: Prior studies applying AI to 12-lead and single-lead ECGs have shown promise for detecting low ejection fraction, but large home-based multicenter validation remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Where this trial is running
Taipei
- 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 (Recruiting)
Study contacts
- Principal investigator: CHIN LIN, PhD — National Defense Medical Center
- Study coordinator: CHIN LIN, PhD
- Email: xup6fup0629@gmail.com
- Phone: +886958259269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.