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Home-based Outpatient Multicenter Evaluation Using Electrocardiogram (HOME-ECG)

RECRUITINGSponsored by National Defense Medical Center, Taiwan
Actively Recruiting
SponsorNational Defense Medical Center, Taiwan
Started2026-03-01
Est. completion2026-06-30
Eligibility
Age20 Years – 90 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07488052

Summary

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

Age: 20 Years – 90 YearsHealthy volunteers accepted
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)

Conditions2

Heart DiseaseHeart Failure

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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