Clinical trial Recruiting at 1 site Observational Ages 20 to 90

Home-based heart check using single-lead ECG

Official title: Prospective Multicenter Validation of a Home-Based Artificial Intelligence Enabled Single-Lead Electrocardiogram for Detecting Low Ejection Fraction and Structural Heart Disease

Run by National Defense Medical Center, Taiwan · NCT07488052 · Data updated 2026-11-12

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 typeObservational
Ages20 Years to 90 Years
SexAll
Enrollment5000 (estimated)
SponsorNational Defense Medical Center, Taiwan
Academic / other
Locations1 site (Taipei)
StatusRecruiting
StartedMarch 1, 2026
Main results expectedJune 30, 2026
Study endsSeptember 30, 2026
Registry record updatedMarch 25, 2026
Trial IDNCT07488052 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.