Heart FailureHOME-ECGNCT07488052
Home-based Outpatient Multicenter Evaluation Using Electrocardiogram (HOME-ECG)
An observational study of Heart Failure, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Single-Lead ECG Acquisition [Apple Watch and QOCA ECG102D]
- How many people
- 5,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2026to 30 Sep 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
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
CHIN LIN, 0958259269, xup6fup0629@gmail.com
About this study
Official title: Prospective Multicenter Validation of a Home-Based Artificial Intelligence Enabled Single-Lead Electrocardiogram for Detecting Low Ejection Fraction and Structural Heart Disease
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
- Heart Failure
- Being tested
- Single-Lead ECG Acquisition [Apple Watch and QOCA ECG102D]
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Single-Lead ECG Acquisition [Apple Watch and QOCA ECG102D] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Secondary outcomes (2)
Positive Predictive Value and Negative Predictive Value for Structural Heart Disease at the Pre-specified Operating Threshold
Prevalence of structural heart disease in patients identified as positive and negative by AI-ECG for detecting low EF, including left atrial enlargement, valvular heart disease, pulmonary hypertension, left ventricular hypertrophy, etc.
Measured: 30 days
Difference in All-Cause Mortality Risk at the Pre-specified Operating Threshold
All-cause mortality risk in patients identified as positive and negative by AI-ECG for detecting low EF.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Mar 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital, Far Eastern Memorial Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chi Mei Medical Hospital, China Medical University Hospital
- Responsible party
- Principal investigator, Chin Lin, National Defense Medical Center, Taiwan
- Investigators
- CHIN LIN, PhD, Principal investigator, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488052
- Sponsor's protocol ID
- NSTC114-2321-B-016-005
- Acronym
- HOME-ECG
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data are not planned for public sharing. Aggregate summary results may be reported in publications and registry updates.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Validation of a Home-Based Artificial Intelligence Enabled Single-Lead Electrocardiogram for Detecting Low Ejection Fraction and Structural Heart Disease
- ClinicalTrials.gov ID
- NCT07488052
- Acronym / sponsor ID
- HOME-ECG / NSTC114-2321-B-016-005
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital, Far Eastern Memorial Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chi Mei Medical Hospital, China Medical University Hospital
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Validation Cohort | – | Diagnostic Test: Single-Lead ECG Acquisition [Apple Watch and QOCA ECG102D]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. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Prospective Validation Cohort |
Primary outcome
Area Under the Receiver Operating Characteristic Curve for Detection of Low Left Ventricular Ejection Fraction
Time frame: 30 days
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.
Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value for Low EF Detection at the Pre-specified Operating Threshold
Time frame: 30 days
Diagnostic operating characteristics of the locked AI model for low EF at the pre-specified threshold.
2 secondary outcomes
Positive Predictive Value and Negative Predictive Value for Structural Heart Disease at the Pre-specified Operating Threshold
Time frame: 30 days
Difference in All-Cause Mortality Risk at the Pre-specified Operating Threshold
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data are not planned for public sharing. Aggregate summary results may be reported in publications and registry updates.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
CHIN LIN, PhD principal investigator
National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHIN LIN, PhD (+886958259269, xup6fup0629@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic Curve for Detection of Low Left Ventricular Ejection Fraction (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.