NCT07488052

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Mar 2026Sep 2026

Study Start

First participant enrolled

March 1, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 17, 2026

Last Update Submit

March 21, 2026

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Positive Predictive Value and Negative Predictive Value for Structural Heart Disease at the Pre-specified Operating Threshold

    30 days

  • Difference in All-Cause Mortality Risk at the Pre-specified Operating Threshold

    90 days

Study Arms (1)

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.

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

Interventions

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.

Prospective Validation Cohort

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, 114, Taiwan

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • CHIN LIN, PhD

    National Defense Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CHIN LIN, PhD

CONTACT

+886958259269xup6fup0629@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data are not planned for public sharing. Aggregate summary results may be reported in publications and registry updates.

Locations

TW(1)