Primary Care ProviderDAISEA-ECGNCT06637293
Deployment and Evaluation of Artificial Intelligence Software for Electrocardiogram Analysis and Management in Primary Care
A study testing DeepECG plateform diagnosis & recommendations in people with Primary Care Provider and Structural Heart Disease, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
The DAISEA-ECG project aims to improve the diagnosis of heart diseases in primary care through the DeepECG platform, which combines ECG-AI and ECHONeXT algorithms. This study uses a stepped wedge design, where each Family Medicine Group acts as its own control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Care Provider, Structural Heart Disease
- What is being tested?
- DeepECG plateform diagnosis & recommendations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2025to Mar 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Family Physicians or Nurse Practitioners
- Family physicians or nurse practitioners (NPs) practicing in one of the participating FMGs.
- Family physicians who have given their free and informed consent. Patients
- Adult patients (18 years or older). Patients without follow-up in cardiology or internal medicine for cardiovascular issues (arrhythmia, heart failure, myocardial infarction, atherosclerotic coronary artery disease, valvular heart disease) or those who had a negative investigation in the past with no additional follow-up.
- ECG
- Any 12-lead ECG performed with the MUSE GE 360 machine. ECG of adequate technical quality for interpretation (otherwise, it will be automatically rejected by the platform).
- -
Who cannot join
- Family Physicians or Nurse Practitioners
- Family physicians practicing exclusively in pediatrics (patients under 18 years old).
- Family physicians unable to follow the project guidelines.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The DAISEA-ECG project aims to improve the diagnosis of heart diseases in primary care through the DeepECG platform, which combines ECG-AI and ECHONeXT algorithms. This study uses a stepped wedge design, where each Family Medicine Group acts as its own control. The FMGs will gradually transition from the control period (without AI recommendations) to the intervention period (with AI recommendations activated) in a randomized sequence.
The primary objective is to compare the sensitivity of family physicians in detecting cardiac pathologies, with and without the assistance of the DeepECG platform. Sensitivity is defined as the proportion of patients correctly referred to cardiology or for transthoracic echocardiography (TTE) among those who indeed required cardiovascular evaluation, as confirmed by an independent adjudication committee.
Read the detailed description
Mathematically, sensitivity is calculated as True Positive / (True Positive + False Negative), where True Positive represents correctly referred patients and false negatives represents patients who should have been referred but were not.
The secondary objectives include determining the rate of cardiovascular evaluation referrals before and after the intervention (implementation of the DeepECG platform), the individual characteristics of the intervention (PPV, NPV, and specificity), as well as evaluating the feasibility of implementing AI-based automatic ECG interpretation in primary care through surveys of family physicians and cardiologists.
PPV: Positive predictive value NPV: Negative predictive value
- Conditions
- Primary Care Provider, Structural Heart Disease
- Being tested
- DeepECG plateform diagnosis & recommendations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeepECG plateform diagnosis & recommendationsDevice
EchoNeXT\& ECG-AI algorithm
| Study group | Role | What they receive |
|---|---|---|
| No DeepECG plateform diagnosis & recommendations | No intervention | Not described |
| DeepECG plateform diagnosis & recommendations | Experimental | Not described Receives: Device: DeepECG plateform diagnosis & recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of cardiology referrals
Compare the sensitivity of cardiology referrals made by family physicians and nurse practitioners before and after the activation of AI-assisted diagnostics and recommendations from the DeepECG platform.
Measured: 18 months
Secondary outcomes (1)
specificity, negative predictive value, and positive predictive value of cardiology referrals
Compare the specificity, negative predictive value, and positive predictive value of cardiology referrals made by family physicians and nurse practitioners before and after the activation of AI-assisted diagnostics and recommendations.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start2 Oct 2025
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Care ProviderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- stepped wedge randomization
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Avram, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637293
- Sponsor's protocol ID
- DAISEA-ECG
- Acronym
- DAISEA-ECG
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deployment and Evaluation of Artificial Intelligence Software for Electrocardiogram Analysis and Management in Primary Care
- ClinicalTrials.gov ID
- NCT06637293
- Acronym / sponsor ID
- DAISEA-ECG / DAISEA-ECG
- Conditions
- Primary Care Provider, Structural Heart Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Oct 2024 (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.
The DAISEA-ECG project aims to improve the diagnosis of heart diseases in primary care through the DeepECG platform, which combines ECG-AI and ECHONeXT algorithms. This study uses a stepped wedge design, where each Family Medicine Group acts as its own control. The FMGs will gradually transition from the control period (without AI recommendations) to the intervention period (with AI recommendations activated) in a randomized sequence.
The primary objective is to compare the sensitivity of family physicians in detecting cardiac pathologies, with and without the assistance of the DeepECG platform. Sensitivity is defined as the proportion of patients correctly referred to cardiology or for transthoracic echocardiography (TTE) among those who indeed required cardiovascular evaluation, as confirmed by an independent adjudication committee.
Detailed description
Mathematically, sensitivity is calculated as True Positive / (True Positive + False Negative), where True Positive represents correctly referred patients and false negatives represents patients who should have been referred but were not.
The secondary objectives include determining the rate of cardiovascular evaluation referrals before and after the intervention (implementation of the DeepECG platform), the individual characteristics of the intervention (PPV, NPV, and specificity), as well as evaluating the feasibility of implementing AI-based automatic ECG interpretation in primary care through surveys of family physicians and cardiologists.
PPV: Positive predictive value NPV: Negative predictive value
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- stepped wedge randomization
| Arm | Type | Receives |
|---|---|---|
| No DeepECG plateform diagnosis & recommendations | No intervention | – |
| DeepECG plateform diagnosis & recommendations | Experimental | Device: DeepECG plateform diagnosis & recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Family Physicians or Nurse Practitioners
- Family physicians or nurse practitioners (NPs) practicing in one of the participating FMGs.
- Family physicians who have given their free and informed consent. Patients
- Adult patients (18 years or older). Patients without follow-up in cardiology or internal medicine for cardiovascular issues (arrhythmia, heart failure, myocardial infarction, atherosclerotic coronary artery disease, valvular heart disease) or those who had a negative investigation in the past with no additional follow-up.
- ECG
Key exclusion criteria (3 listed)
- Family Physicians or Nurse Practitioners
- Family physicians practicing exclusively in pediatrics (patients under 18 years old).
- Family physicians unable to follow the project guidelines.
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 |
|---|---|---|
| DeepECG plateform diagnosis & recommendationsEchoNeXT\& ECG-AI algorithm | Device | DeepECG plateform diagnosis & recommendations |
Primary outcome
sensitivity of cardiology referrals
Time frame: 18 months
Compare the sensitivity of cardiology referrals made by family physicians and nurse practitioners before and after the activation of AI-assisted diagnostics and recommendations from the DeepECG platform.
1 secondary outcome
specificity, negative predictive value, and positive predictive value of cardiology referrals
Time frame: 18 months
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 8 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DeepECG plateform diagnosis & recommendations in people with Primary Care Provider and Structural Heart Disease, run by Montreal Heart Institute at 1 site in Canada.
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 7 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: enrolling by invitation, as of the sponsor's last update on 8 Oct 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 Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of cardiology referrals (time frame: 18 months). 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 8 Oct 2026.