Structural Heart AbnormalityHEART-AINCT06462989
Harnessing ECG Artificial Intelligence for Rapid Treatment and Accurate Interpretation
A study testing ECHONEXT in people with Structural Heart Abnormality and Structural Heart Disease, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
HEART-AI is a pragmatic randomized trial currently active at Montreal Heart Institute, with planned multicenter expansion testing whether an artificial intelligence (AI) score from a routine 12-lead electrocardiogram (ECG) helps clinicians identify structural heart disease sooner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Structural Heart Abnormality, Structural Heart Disease
- What is being tested?
- ECHONEXT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,700 participants
- Where
- 1 siteCanada
- Study dates
- 16 Apr 2025to Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Providers:
- Licensed healthcare professionals (physicians, nurse practitioners, physician assistants, and residents) who interpret ECGs in ambulatory cardiology clinics or emergency departments and have authority to order TTEs.
- Patients:
- Adults aged 18 years or older presenting to outpatient cardiology clinics or ambulatory emergency departments with unknown structural heart disease (SHD) status.
- Either new patients with no prior cardiac diagnosis and no prior TTE on record, or surveillance patients whose most recent TTE was normal (no SHD) and performed at least 24 months ago.
- ECGs:
- Standard 12-lead ECGs in XML format recorded after study initiation and successfully transmitted to DeepECG.ai.
Who cannot join
- Providers:
- None.
- Patients:
- Inpatient or hospitalized patients at the time of ECG. Patients randomized in the ambulatory emergency department who are subsequently hospitalized remain eligible.
- ECGs:
- Failed automated quality checks, including poor technical quality or indiscernible QRS waveforms.
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
Official title: Harnessing ECG Artificial Intelligence for Rapid Treatment and Accurate Interpretation, an Open Label Randomized Controlled Trial
HEART-AI is a pragmatic randomized trial currently active at Montreal Heart Institute, with planned multicenter expansion testing whether an artificial intelligence (AI) score from a routine 12-lead electrocardiogram (ECG) helps clinicians identify structural heart disease sooner. Structural heart disease includes reduced heart pumping function, valve disease, pulmonary hypertension, thickened heart muscle and fluid around the heart. The study plans to enroll 5,700 adults seen in outpatient clinics or ambulatory emergency departments who have no known structural heart disease.
Patients are assigned equally to standard care with or without the EchoNext AI risk score and echocardiography recommendation. For high-risk patients, EchoNext recommends a transthoracic echocardiogram (TTE, an ultrasound of the heart) within 2 to 4 weeks, no later than 30 days. Low-risk patients receive routine care, with TTE when clinically indicated. Clinicians retain responsibility for all care decisions. The score is calculated in both groups but shown only in the AI group.
The main outcome is the proportion of patients with structural heart disease documented on a clinical TTE within 30 days of their first study ECG. Other outcomes include diagnoses within 12 months, time to TTE and diagnosis, imaging use, management changes and model performance.
Read the detailed description
Design and population HEART-AI is a pragmatic, parallel-group trial currently active at one site, Montreal Heart Institute, with planned multicenter expansion with patient-level 1:1 randomization through DeepECG.ai at review of the first eligible clinically indicated ECG. Randomization is stratified by center, biological sex (administrative sex as proxy), and setting (outpatient versus ambulatory emergency department), using permuted blocks of varying size. Allocation remains fixed for subsequent ECGs; only the first ECG is analyzed. The planned expansion includes Montreal Heart Institute (MHI), McGill University Health Centre, University of Ottawa Heart Institute, Jewish General Hospital, University Health Network, Marienkrankenhaus Hamburg, Sorel and Joliette. Each new site activates only after ethics approval and an executed data-processing agreement. Study completion is anticipated in 2027. MHI completed setup in 2025 and continues randomizing. The target is 5,700 patients.
Intervention and workflow Providers confirm eligibility before randomization and record their TTE ordering intent and intended priority before any AI result is displayed. The intervention arm receives standard care plus the EchoNext SHD risk score and TTE recommendation: high risk, TTE within 2 to 4 weeks (≤30 days); low risk, routine care and TTE only if clinically indicated. The control arm receives standard ECG interpretation and clinical judgment without displayed AI scores or recommendations. Scores are computed in both arms. Providers manage both arms and retain full clinical autonomy. The post-ECG form records TTE referral, intended priority (≤30 or >30 days), and AI use in the intervention arm. Model weights remain frozen throughout the trial.
SHD definition and outcome ascertainment SHD is any of: LVEF ≤45% measured by Simpson biplane; moderate or greater RV systolic dysfunction (TAPSE ≤17 mm, fractional area change ≤35%, or moderate-or-worse impairment on visual assessment); systolic pulmonary artery pressure ≥45 mm Hg; moderate or greater mitral, tricuspid, pulmonic or aortic regurgitation or aortic stenosis; septal or posterior LV wall thickness ≥1.3 cm; or moderate or large pericardial effusion. Two trained abstractors blinded to arm assess clinical TTE reports. Disagreements are adjudicated by a study cardiologist not involved in the patient's care.
The primary numerator is any qualifying clinical TTE documenting SHD within 30 days of the index ECG; the denominator is all randomized patients. The earliest SHD-positive clinical TTE is used. Patients without an accessible qualifying result at 30 days, including deaths, have no documented 30-day SHD diagnosis. Each SHD component is reported separately by arm. Primary analysis follows intention-to-treat and uses GEE logistic regression adjusted for center, sex and setting, clustered on provider. Secondary time-to-TTE and time-to-SHD analyses censor at 12 months and treat death as a competing event. Clinical and process outcomes are also reported by biological sex.
Monitoring A blinded interim at approximately 2,850 patients re-estimates the pooled 30-day SHD rate. There is no early stopping for efficacy or futility. No DSMB is constituted. An independent safety officer with no role in trial conduct or platform development reviews safety every 6 months, focusing on low-risk under-diagnosis and TTEs performed beyond the intended priority window. Seriant conducts independent analyses.
Outcome amendment rationale, October 4, 2026 The primary outcome is revised from time to SHD diagnosis to the proportion of randomized patients with clinical TTE-documented SHD within 30 days, aligning the registry with the revised multicenter grant's primary objective and sample-size calculation. This measures whether AI-guided prioritization closes the gap in timely SHD detection. Time to SHD diagnosis is retained as a secondary outcome with follow-up through 12 months.
This outcome amendment precedes any unblinded comparison of randomized study arms. There is no verification TTE substudy.
- Being tested
- ECHONEXT
- Keywords
- artificial intelligence, transthoracic echocardiogram, magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHONEXTOther
EchoNext is an ECG-based artificial intelligence algorithm that predicts structural heart disease from a clinically indicated 12-lead ECG. Through DeepECG.ai, intervention-arm providers receive the SHD risk score and a TTE priority recommendation: high risk, TTE within 2 to 4 weeks (≤30 days); low risk, routine care and TTE only if clinically indicated. Scores are computed in both randomized arms but are displayed only in the intervention arm. Model weights remain frozen throughout the trial. This is single-encounter clinical decision support; providers retain full autonomy over referral and management.
| Study group | Role | What they receive |
|---|---|---|
| EchoNext AI-ECG risk score plus standard care | Experimental | Standard care plus the EchoNext structural heart disease risk score and TTE priority recommendation displayed through DeepECG.ai at review of the index 12-lead ECG. High risk: recommend TTE within 2 to 4 weeks (≤30 days). Low risk: routine care, TTE only if clinically indicated, and symptom monitoring. Scores are computed in both arms but displayed only in this arm. Model weights remain frozen for the trial. Before display, providers record TTE ordering intent and intended priority; after ECG review they record final referral and intended priority (≤30 or >30 days). Providers retain full clinical autonomy. Receives: Other: ECHONEXT |
| Standard care without displayed EchoNext guidance | No intervention | Standard ECG interpretation with clinician judgment and physical examination for TTE referral. EchoNext SHD risk scores are computed but neither the score nor the TTE recommendation is displayed to providers. Before ECG interpretation, providers record TTE ordering intent and intended priority; final referral and intended priority (≤30 or >30 days) are recorded afterward. Providers retain full access to medical records and full clinical autonomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of randomized patients with TTE-documented structural heart disease within 30 days
Proportion of all randomized patients with at least one clinical TTE demonstrating prespecified structural heart disease (SHD) within 30 days of the index ECG, analyzed by intention-to-treat. SHD is any of: LVEF ≤45% by Simpson biplane; moderate or greater RV dysfunction (TAPSE ≤17 mm, fractional area change ≤35%, or moderate-or-worse visual impairment); systolic pulmonary artery pressure ≥45 mm Hg; moderate or greater mitral, tricuspid, pulmonic or aortic regurgitation or aortic stenosis; septal or posterior LV wall thickness ≥1.3 cm; or moderate or large pericardial effusion. Clinical TTE reports are abstracted by two assessors blinded to arm, with disagreements adjudicated. The earliest SHD-positive clinical TTE is used. Patients without an accessible qualifying clinical TTE result by day 30, including deaths, have no documented 30-day SHD diagnosis.
Measured: 30 days from the index ECG
Secondary outcomes (17)
Proportion of randomized patients with TTE-documented structural heart disease within 12 months
Proportion of all randomized patients with echocardiographically-confirmed SHD on clinical TTE within 12 months of the index ECG, compared between arms using the prespecified SHD composite defined in the primary outcome. Outcome assessment is blinded to randomized arm. Analyses are reported overall and by biological sex.
Measured: 12 months from the index ECG
Time from index ECG to clinical TTE
Time from the index ECG to the first completed clinical TTE, compared between randomized arms overall and by EchoNext risk class. Time-to-event analyses include all randomized patients, censor at 12 months, and treat death as a competing event. Analyses are also reported by biological sex.
Measured: 12 months from the index ECG
Intended TTE priority at the index ECG
Proportion of patients assigned intended TTE priority ≤30 days versus >30 days on the post-ECG questionnaire, compared between randomized arms overall and by EchoNext risk class and biological sex.
Measured: At baseline
Provider concordance with EchoNext TTE recommendations
Proportion of intervention-arm patients for whom a TTE is ordered within the EchoNext recommended window, overall and stratified by EchoNext risk class. High-risk patients are recommended TTE within 2 to 4 weeks (≤30 days); low-risk patients receive routine care with TTE when clinically indicated.
Measured: At baseline
Time from index ECG to SHD diagnosis
Time from the index ECG to the first clinical TTE documenting the prespecified SHD composite defined in the primary outcome. Analyze all randomized patients, censor at 12 months, and treat death as a competing event. Compare arms overall and by EchoNext risk class and biological sex. This outcome was retained as secondary when the primary outcome was changed to documented SHD within 30 days.
Measured: 12 months from the index ECG
Diagnostic yield of clinical TTE
Number of patients with SHD diagnosed on completed clinical TTE divided by the number of completed clinical TTEs, compared between arms overall and by EchoNext risk class. In high-risk patients, also report incremental yield as the arm difference in 30-day SHD diagnoses divided by the arm difference in completed 30-day clinical TTEs.
Measured: 30 days from the index ECG
Net clinical TTE volume per 100 randomized patients
Number of completed clinical TTEs per 100 randomized patients and the between-arm difference, overall and by EchoNext risk class. Also report clinical TTEs per SHD diagnosis to distinguish added imaging from improved targeting.
Measured: 30 days from the index ECG
Documented management change after SHD diagnosis
Proportion of patients diagnosed with SHD who have a documented specialty referral, initiation or uptitration of guideline-directed therapy, structural intervention, or right heart catheterization within 12 months. Compare randomized arms overall and by biological sex.
Measured: 12 months from the index ECG
SHD diagnosis in low-risk patients by randomized arm
Proportion of low-risk randomized patients with clinical TTE-documented SHD within 30 days, compared between arms as a safety and falsification outcome. A low-risk deficit may indicate under-diagnosis from deprioritization; an excess is interpreted as contamination or chance.
Measured: 30 days from the index ECG
EchoNext diagnostic performance and algorithmic fairness
Sensitivity, specificity, positive and negative predictive values of EchoNext against clinical TTE-confirmed SHD within 30 days in the control arm; intervention-arm estimates are reported separately. Assess equalized odds, calibration slope and predictive parity across age (<65, 65-84, ≥85 years) and biological sex subgroups. Trial model weights remain frozen; subgroup recalibration is reported as a secondary analysis without changing the deployed model.
Measured: 30 days from the index ECG
Pre-display TTE intent versus final referral decision
Compare the clinician's TTE-ordering intent and intended priority recorded before any AI result is displayed with the final post-ECG referral decision and intended priority (≤30 versus >30 days), by randomized arm and EchoNext risk class.
Measured: At baseline
Reduced left ventricular ejection fraction diagnosed on clinical TTE
Proportion of randomized patients with LVEF ≤45% measured by Simpson biplane on clinical TTE, reported separately by arm and biological sex as a component of the prespecified SHD composite.
Measured: 30 days from the index ECG
Reduced right ventricular systolic function diagnosed on clinical TTE
Proportion of randomized patients with moderate or greater RV dysfunction: TAPSE ≤17 mm, fractional area change ≤35%, or moderate-or-worse visual impairment. Report separately by arm and biological sex.
Measured: 30 days from the index ECG
Pulmonary hypertension diagnosed on clinical TTE
Proportion of randomized patients with systolic pulmonary artery pressure ≥45 mm Hg on clinical TTE, reported separately by arm and biological sex as a component of the SHD composite.
Measured: 30 days from the index ECG
Valvular heart disease diagnosed on clinical TTE
Proportion of randomized patients with moderate or greater mitral, tricuspid, pulmonic or aortic regurgitation, or aortic stenosis, on clinical TTE. Each valve lesion is reported separately by arm and biological sex as a component of the prespecified SHD composite.
Measured: 30 days from the index ECG
Left ventricular hypertrophy diagnosed on clinical TTE
Proportion of randomized patients with septal or posterior LV wall thickness ≥1.3 cm on clinical TTE, reported separately by arm and biological sex as a component of the SHD composite.
Measured: 30 days from the index ECG
Pericardial effusion diagnosed on clinical TTE
Proportion of randomized patients with moderate or large pericardial effusion on clinical TTE, reported separately by arm and biological sex as a component of the SHD composite.
Measured: 30 days from the index ECG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start16 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Structural Heart AbnormalityStudies 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
- Pragmatic parallel-group trial currently active at Montreal Heart Institute, with planned multicenter expansion. Patient-level 1:1 randomization at review of the first eligible ECG uses concealed permuted blocks of varying size, stratified by center, biological sex (administrative sex as proxy), and ambulatory setting (outpatient versus emergency department). Allocation remains fixed for subsequent ECGs; only the first is analyzed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,700 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
- NCT06462989
- Sponsor's protocol ID
- HEART-AI-001
- Acronym
- HEART-AI
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2024
- Last updated
- 13 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing ECG Artificial Intelligence for Rapid Treatment and Accurate Interpretation, an Open Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06462989
- Acronym / sponsor ID
- HEART-AI / HEART-AI-001
- Keywords
- artificial intelligence, transthoracic echocardiogram, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,700 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jun 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.
HEART-AI is a pragmatic randomized trial currently active at Montreal Heart Institute, with planned multicenter expansion testing whether an artificial intelligence (AI) score from a routine 12-lead electrocardiogram (ECG) helps clinicians identify structural heart disease sooner. Structural heart disease includes reduced heart pumping function, valve disease, pulmonary hypertension, thickened heart muscle and fluid around the heart. The study plans to enroll 5,700 adults seen in outpatient clinics or ambulatory emergency departments who have no known structural heart disease.
Patients are assigned equally to standard care with or without the EchoNext AI risk score and echocardiography recommendation. For high-risk patients, EchoNext recommends a transthoracic echocardiogram (TTE, an ultrasound of the heart) within 2 to 4 weeks, no later than 30 days. Low-risk patients receive routine care, with TTE when clinically indicated. Clinicians retain responsibility for all care decisions. The score is calculated in both groups but shown only in the AI group.
The main outcome is the proportion of patients with structural heart disease documented on a clinical TTE within 30 days of their first study ECG. Other outcomes include diagnoses within 12 months, time to TTE and diagnosis, imaging use, management changes and model performance.
Detailed description
Design and population HEART-AI is a pragmatic, parallel-group trial currently active at one site, Montreal Heart Institute, with planned multicenter expansion with patient-level 1:1 randomization through DeepECG.ai at review of the first eligible clinically indicated ECG. Randomization is stratified by center, biological sex (administrative sex as proxy), and setting (outpatient versus ambulatory emergency department), using permuted blocks of varying size. Allocation remains fixed for subsequent ECGs; only the first ECG is analyzed. The planned expansion includes Montreal Heart Institute (MHI), McGill University Health Centre, University of Ottawa Heart Institute, Jewish General Hospital, University Health Network, Marienkrankenhaus Hamburg, Sorel and Joliette. Each new site activates only after ethics approval and an executed data-processing agreement. Study completion is anticipated in 2027. MHI completed setup in 2025 and continues randomizing. The target is 5,700 patients.
Intervention and workflow Providers confirm eligibility before randomization and record their TTE ordering intent and intended priority before any AI result is displayed. The intervention arm receives standard care plus the EchoNext SHD risk score and TTE recommendation: high risk, TTE within 2 to 4 weeks (≤30 days); low risk, routine care and TTE only if clinically indicated. The control arm receives standard ECG interpretation and clinical judgment without displayed AI scores or recommendations. Scores are computed in both arms. Providers manage both arms and retain full clinical autonomy. The post-ECG form records TTE referral, intended priority (≤30 or >30 days), and AI use in the intervention arm. Model weights remain frozen throughout the trial.
SHD definition and outcome ascertainment SHD is any of: LVEF ≤45% measured by Simpson biplane; moderate or greater RV systolic dysfunction (TAPSE ≤17 mm, fractional area change ≤35%, or moderate-or-worse impairment on visual assessment); systolic pulmonary artery pressure ≥45 mm Hg; moderate or greater mitral, tricuspid, pulmonic or aortic regurgitation or aortic stenosis; septal or posterior LV wall thickness ≥1.3 cm; or moderate or large pericardial effusion. Two trained abstractors blinded to arm assess clinical TTE reports. Disagreements are adjudicated by a study cardiologist not involved in the patient's care.
The primary numerator is any qualifying clinical TTE documenting SHD within 30 days of the index ECG; the denominator is all randomized patients. The earliest SHD-positive clinical TTE is used. Patients without an accessible qualifying result at 30 days, including deaths, have no documented 30-day SHD diagnosis. Each SHD component is reported separately by arm. Primary analysis follows intention-to-treat and uses GEE logistic regression adjusted for center, sex and setting, clustered on provider. Secondary time-to-TTE and time-to-SHD analyses censor at 12 months and treat death as a competing event. Clinical and process outcomes are also reported by biological sex.
Monitoring A blinded interim at approximately 2,850 patients re-estimates the pooled 30-day SHD rate. There is no early stopping for efficacy or futility. No DSMB is constituted. An independent safety officer with no role in trial conduct or platform development reviews safety every 6 months, focusing on low-risk under-diagnosis and TTEs performed beyond the intended priority window. Seriant conducts independent analyses.
Outcome amendment rationale, October 4, 2026 The primary outcome is revised from time to SHD diagnosis to the proportion of randomized patients with clinical TTE-documented SHD within 30 days, aligning the registry with the revised multicenter grant's primary objective and sample-size calculation. This measures whether AI-guided prioritization closes the gap in timely SHD detection. Time to SHD diagnosis is retained as a secondary outcome with follow-up through 12 months.
This outcome amendment precedes any unblinded comparison of randomized study arms. There is no verification TTE substudy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic parallel-group trial currently active at Montreal Heart Institute, with planned multicenter expansion. Patient-level 1:1 randomization at review of the first eligible ECG uses concealed permuted blocks of varying size, stratified by center, biological sex (administrative sex as proxy), and ambulatory setting (outpatient versus emergency department). Allocation remains fixed for subsequent ECGs; only the first is analyzed.
| Arm | Type | Receives |
|---|---|---|
| EchoNext AI-ECG risk score plus standard care | Experimental | Other: ECHONEXTStandard care plus the EchoNext structural heart disease risk score and TTE priority recommendation displayed through DeepECG.ai at review of the index 12-lead ECG. High risk: recommend TTE within 2 to 4 weeks (≤30 days). Low risk: routine care, TTE only if clinically indicated, and symptom monitoring. Scores are computed in both arms but displayed only in this arm. Model weights remain frozen for the trial. Before display, providers record TTE ordering intent and intended priority; after ECG review they record final referral and intended priority (≤30 or >30 days). Providers retain full clinical autonomy. |
| Standard care without displayed EchoNext guidance | No intervention | –Standard ECG interpretation with clinician judgment and physical examination for TTE referral. EchoNext SHD risk scores are computed but neither the score nor the TTE recommendation is displayed to providers. Before ECG interpretation, providers record TTE ordering intent and intended priority; final referral and intended priority (≤30 or >30 days) are recorded afterward. Providers retain full access to medical records and full clinical autonomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Licensed healthcare professionals (physicians, nurse practitioners, physician assistants, and residents) who interpret ECGs in ambulatory cardiology clinics or emergency departments and have authority to order TTEs.
- Adults aged 18 years or older presenting to outpatient cardiology clinics or ambulatory emergency departments with unknown structural heart disease (SHD) status.
- Either new patients with no prior cardiac diagnosis and no prior TTE on record, or surveillance patients whose most recent TTE was normal (no SHD) and performed at least 24 months ago.
- Standard 12-lead ECGs in XML format recorded after study initiation and successfully transmitted to DeepECG.ai.
Key exclusion criteria (6 listed)
- None.
- Inpatient or hospitalized patients at the time of ECG. Patients randomized in the ambulatory emergency department who are subsequently hospitalized remain eligible.
- Failed automated quality checks, including poor technical quality or indiscernible QRS waveforms.
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 |
|---|---|---|
| ECHONEXTEchoNext is an ECG-based artificial intelligence algorithm that predicts structural heart disease from a clinically indicated 12-lead ECG. Through DeepECG.ai, intervention-arm providers receive the SHD risk score and a TTE priority recommendation: high risk, TTE within 2 to 4 weeks (≤30 days); low risk, routine care and TTE only if clinically indicated. Scores are computed in both randomized arms but are displayed only in the intervention arm. Model weights remain frozen throughout the trial. This is single-encounter clinical decision support; providers retain full autonomy over referral and management. | Other | EchoNext AI-ECG risk score plus standard care |
Primary outcome
Proportion of randomized patients with TTE-documented structural heart disease within 30 days
Time frame: 30 days from the index ECG
Proportion of all randomized patients with at least one clinical TTE demonstrating prespecified structural heart disease (SHD) within 30 days of the index ECG, analyzed by intention-to-treat. SHD is any of: LVEF ≤45% by Simpson biplane; moderate or greater RV dysfunction (TAPSE ≤17 mm, fractional area change ≤35%, or moderate-or-worse visual impairment); systolic pulmonary artery pressure ≥45 mm Hg; moderate or greater mitral, tricuspid, pulmonic or aortic regurgitation or aortic stenosis; septal or posterior LV wall thickness ≥1.3 cm; or moderate or large pericardial effusion. Clinical TTE reports are abstracted by two assessors blinded to arm, with disagreements adjudicated. The earliest SHD-positive clinical TTE is used. Patients without an accessible qualifying clinical TTE result by day 30, including deaths, have no documented 30-day SHD diagnosis.
17 secondary outcomes
Proportion of randomized patients with TTE-documented structural heart disease within 12 months
Time frame: 12 months from the index ECG
Time from index ECG to clinical TTE
Time frame: 12 months from the index ECG
Intended TTE priority at the index ECG
Time frame: At baseline
Provider concordance with EchoNext TTE recommendations
Time frame: At baseline
Time from index ECG to SHD diagnosis
Time frame: 12 months from the index ECG
Diagnostic yield of clinical TTE
Time frame: 30 days from the index ECG
Net clinical TTE volume per 100 randomized patients
Time frame: 30 days from the index ECG
Documented management change after SHD diagnosis
Time frame: 12 months from the index ECG
SHD diagnosis in low-risk patients by randomized arm
Time frame: 30 days from the index ECG
EchoNext diagnostic performance and algorithmic fairness
Time frame: 30 days from the index ECG
Pre-display TTE intent versus final referral decision
Time frame: At baseline
Reduced left ventricular ejection fraction diagnosed on clinical TTE
Time frame: 30 days from the index ECG
Reduced right ventricular systolic function diagnosed on clinical TTE
Time frame: 30 days from the index ECG
Pulmonary hypertension diagnosed on clinical TTE
Time frame: 30 days from the index ECG
Valvular heart disease diagnosed on clinical TTE
Time frame: 30 days from the index ECG
Left ventricular hypertrophy diagnosed on clinical TTE
Time frame: 30 days from the index ECG
Pericardial effusion diagnosed on clinical TTE
Time frame: 30 days from the index ECG
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 13 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 ECHONEXT in people with Structural Heart Abnormality 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 6 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 13 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?
Proportion of randomized patients with TTE-documented structural heart disease within 30 days (time frame: 30 days from the index ECG). 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 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.