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

NCT07488052 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Single-Lead ECG Acquisition [Apple Watch and QOCA ECG102D]

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.

Sponsors & Collaborators

  • Taipei Medical University WanFang Hospital

    collaborator OTHER

  • Far Eastern Memorial Hospital

    collaborator OTHER

  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    collaborator OTHER

  • Chi Mei Medical Hospital

    collaborator OTHER

  • China Medical University Hospital

    collaborator OTHER

  • National Defense Medical Center, Taiwan

    lead OTHER

Principal Investigators

  • CHIN LIN, PhD · National Defense Medical Center

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-06-30
Completion
2026-09-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07488052 on ClinicalTrials.gov