Low-gradient Aortic StenosisASAI-POLNCT07144189
AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography
An observational study of Low-gradient Aortic Stenosis and Aortic Stenosis, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
The purpose of this study is to evaluate the effectiveness of an artificial intelligence (AI) model developed by the investigators for identifying severe low-gradient aortic valve stenosis. Accurate assessment of stenosis severity is crucial for proper qualification for surgical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low-gradient Aortic Stenosis, Aortic Stenosis
- What is being tested?
- AI diagnostic test for severe low-gradient aortic stenosis
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 20 Aug 2025to 20 Aug 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include adult patients (≥18 years) diagnosed in the Echocardiography Laboratory of the National Institute of Cardiology in Warsaw, Department of Valvular Heart Disease. Eligible participants will be those referred for echocardiographic evaluation due to clinical suspicion of significant low-gradient aortic stenosis. Standard-of-care imaging performed for clinical indications will be analyzed. Approximately 300 patients are expected to be enrolled between 2025 and 2026. Patients with previous aortic valve intervention (surgical or transcatheter) or other exclusion criteria will not be included.
Who may be able to join
- Age ≥ 18 years
- Clinical suspicion of significant low-gradient aortic stenosis
- Echocardiographic examination performed for clinical indications
- Ability to provide informed consent
Who cannot join
- Previous aortic valve intervention (surgical or transcatheter)
- Inadequate image quality precluding echocardiographic analysis
- Concomitant severe valvular disease (severe mitral stenosis or mitral/aortic regurgitation) that could confound assessment
- Patients unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland
Warsaw, Masovian Voivodeship
Michał Wrzosek, MD, +48516652370, mwrzosek@ikard.pl
About this study
Official title: Artificial Intelligence-Based Assessment of Low-Gradient Aortic Stenosis Severity Using Echocardiographic Images
The purpose of this study is to evaluate the effectiveness of an artificial intelligence (AI) model developed by the investigators for identifying severe low-gradient aortic valve stenosis. Accurate assessment of stenosis severity is crucial for proper qualification for surgical treatment. It is expected that the use of AI will improve diagnostic accuracy and thereby support better clinical outcomes.
Patients with suspected significant low-gradient aortic stenosis will be enrolled. The study is observational and involves no additional risk for participants. Standard imaging studies performed for clinical indications will be additionally analyzed by the AI model, which will classify aortic stenosis as severe or moderate. The model's results will not influence the clinical management of participants but will be compared with physicians' assessments to validate its diagnostic performance.
The study will be conducted in 2025-2026. The findings will provide insights into the usefulness of AI in the diagnosis of severe aortic stenosis and may contribute to the development of advanced clinical decision-support tools.
Read the detailed description
This study is a prospective multicenter observational validation of an artificial intelligence (AI) model for differentiating severe low-gradient from moderate aortic stenosis using transthoracic echocardiography images. The model, developed and published by the investigators, demonstrated promising diagnostic performance in retrospective data. In the present trial, approximately 300 participants with suspected significant low-gradient aortic stenosis will be enrolled during 2025-2026. Standard imaging studies performed for clinical indications will be analyzed by the AI model, which will classify aortic stenosis as severe or moderate. The AI-derived results will not influence clinical decision-making but will be compared with physicians assessments to evaluate diagnostic accuracy and reproducibility in real-world practice.
- Conditions
- Low-gradient Aortic Stenosis, Aortic Stenosis
- Being tested
- AI diagnostic test for severe low-gradient aortic stenosis
- Keywords
- low-gradient aortic stenosis, Echocardiography, Artificial intelligence, Cardiac imaging, Machine learning
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI diagnostic test for severe low-gradient aortic stenosisDiagnostic test
All participants will undergo standard transthoracic echocardiography performed for clinical indications. Echocardiographic images will be analyzed both by experienced physicians and by the investigational AI model. Additional diagnostic tests (such as cardiac CT, low-dose dobutamine stress echocardiography or transesophageal echocardiography) may be performed if clinically indicated, according to current guideline recommendations. The AI-derived results will not influence clinical decision-making.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected significant low-gradient aortic stenosis. | Approximately 300 patients with suspected significant low-gradient aortic stenosis undergoing standard echocardiographic evaluation between 2025 and 2026. Echocardiographic images will be secondarily analyzed by the AI model to classify stenosis as severe or moderate. The AI results will be compared with physicians assessments. No intervention or modification of clinical care is involved. Receives: Diagnostic Test: AI diagnostic test for severe low-gradient aortic stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic Curve (AUC) describing the sensitivity-specificity relationship of the AI model.
AUC will be calculated to assess the ability of the AI model to differentiate between severe low-gradient and moderate aortic stenosis. The analysis will use physician assessment and guideline-based diagnostic criteria as the reference standard. AUC will be reported with 95% confidence intervals.
Measured: At the time of the nearest Heart Team meeting following the echocardiographic examination (typically within 1 week).
Secondary outcomes (1)
Diagnostic performance of the AI model in clinically relevant subgroups.
Diagnostic performance of the AI model (AUC, sensitivity, specificity) in clinically relevant subgroups, such as patients with atrial fibrillation or subtypes of low-gradient aortic stenosis (classic, paradoxical, normal flow).
Measured: At the nearest Heart Team meeting following the echocardiographic examination (typically within 1 week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start20 Aug 2025
- Primary completion20 Aug 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low-gradient Aortic StenosisStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- The Institute of Bioorganic Chemistry, Polish Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- Tomasz Hryniewiecki, Professor of Medicine, Study chair, Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, PolandMichał Wrzosek, MD, Principal investigator, Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, PolandKarina Zatorska, MD, PhD, Study director, Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144189
- Sponsor's protocol ID
- 4.35/VI/25
- Acronym
- ASAI-POL
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wrzosek M, Buchwald M, Czernik P, Kupinski S, Zatorska K, Jasinska A, Zakrzewski D, Pukacki J, Mazurek C, Pekal R, Hryniewiecki T. Diagnosing Severe Low-Gradient vs Moderate Aortic Stenosis with Artificial Intelligence Based on Echocardiography Images. J Imaging Inform Med. 2026 Feb;39(1):926-932. doi: 10.1007/s10278-025-01497-4. Epub 2025 Apr 21.
PubMed 40259202
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Based Assessment of Low-Gradient Aortic Stenosis Severity Using Echocardiographic Images
- ClinicalTrials.gov ID
- NCT07144189
- Acronym / sponsor ID
- ASAI-POL / 4.35/VI/25
- Conditions
- Low-gradient Aortic Stenosis, Aortic Stenosis
- Keywords
- low-gradient aortic stenosis, Echocardiography, Artificial intelligence, Cardiac imaging, Machine learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Collaborators
- The Institute of Bioorganic Chemistry, Polish Academy of Sciences
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 27 Aug 2025 (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 purpose of this study is to evaluate the effectiveness of an artificial intelligence (AI) model developed by the investigators for identifying severe low-gradient aortic valve stenosis. Accurate assessment of stenosis severity is crucial for proper qualification for surgical treatment. It is expected that the use of AI will improve diagnostic accuracy and thereby support better clinical outcomes.
Patients with suspected significant low-gradient aortic stenosis will be enrolled. The study is observational and involves no additional risk for participants. Standard imaging studies performed for clinical indications will be additionally analyzed by the AI model, which will classify aortic stenosis as severe or moderate. The model's results will not influence the clinical management of participants but will be compared with physicians' assessments to validate its diagnostic performance.
The study will be conducted in 2025-2026. The findings will provide insights into the usefulness of AI in the diagnosis of severe aortic stenosis and may contribute to the development of advanced clinical decision-support tools.
Detailed description
This study is a prospective multicenter observational validation of an artificial intelligence (AI) model for differentiating severe low-gradient from moderate aortic stenosis using transthoracic echocardiography images. The model, developed and published by the investigators, demonstrated promising diagnostic performance in retrospective data. In the present trial, approximately 300 participants with suspected significant low-gradient aortic stenosis will be enrolled during 2025-2026. Standard imaging studies performed for clinical indications will be analyzed by the AI model, which will classify aortic stenosis as severe or moderate. The AI-derived results will not influence clinical decision-making but will be compared with physicians assessments to evaluate diagnostic accuracy and reproducibility in real-world practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected significant low-gradient aortic stenosis. | – | Diagnostic Test: AI diagnostic test for severe low-gradient aortic stenosisApproximately 300 patients with suspected significant low-gradient aortic stenosis undergoing standard echocardiographic evaluation between 2025 and 2026. Echocardiographic images will be secondarily analyzed by the AI model to classify stenosis as severe or moderate. The AI results will be compared with physicians assessments. No intervention or modification of clinical care is involved. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients (≥18 years) diagnosed in the Echocardiography Laboratory of the National Institute of Cardiology in Warsaw, Department of Valvular Heart Disease. Eligible participants will be those referred for echocardiographic evaluation due to clinical suspicion of significant low-gradient aortic stenosis. Standard-of-care imaging performed for clinical indications will be analyzed. Approximately 300 patients are expected to be enrolled between 2025 and 2026. Patients with previous aortic valve intervention (surgical or transcatheter) or other exclusion criteria will not be included.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Clinical suspicion of significant low-gradient aortic stenosis
- Echocardiographic examination performed for clinical indications
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Previous aortic valve intervention (surgical or transcatheter)
- Inadequate image quality precluding echocardiographic analysis
- Concomitant severe valvular disease (severe mitral stenosis or mitral/aortic regurgitation) that could confound assessment
- Patients unwilling or unable to provide informed consent
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 |
|---|---|---|
| AI diagnostic test for severe low-gradient aortic stenosisAll participants will undergo standard transthoracic echocardiography performed for clinical indications. Echocardiographic images will be analyzed both by experienced physicians and by the investigational AI model. Additional diagnostic tests (such as cardiac CT, low-dose dobutamine stress echocardiography or transesophageal echocardiography) may be performed if clinically indicated, according to current guideline recommendations. The AI-derived results will not influence clinical decision-making. | Diagnostic test | Patients with suspected significant low-gradient aortic stenosis. |
Primary outcome
Area Under the Receiver Operating Characteristic Curve (AUC) describing the sensitivity-specificity relationship of the AI model.
Time frame: At the time of the nearest Heart Team meeting following the echocardiographic examination (typically within 1 week).
AUC will be calculated to assess the ability of the AI model to differentiate between severe low-gradient and moderate aortic stenosis. The analysis will use physician assessment and guideline-based diagnostic criteria as the reference standard. AUC will be reported with 95% confidence intervals.
1 secondary outcome
Diagnostic performance of the AI model in clinically relevant subgroups.
Time frame: At the nearest Heart Team meeting following the echocardiographic examination (typically within 1 week).
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 2 Dec 2025.
- Results publication: PubMed 40259202Wrzosek M, Buchwald M, Czernik P, Kupinski S, Zatorska K, Jasinska A, Zakrzewski D, Pukacki J, Mazurek C, Pekal R, Hryniewiecki T. Diagnosing Severe Low-Gradient vs Moderate Aortic Stenosis with Artificial Intelligence Based on Echocardiography Images. J Imaging Inform Med. 2026 Feb;39(1):926-932. doi: 10.1007/s10278-025-01497-4. Epub 2025 Apr 21.
- 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.
Tomasz Hryniewiecki, Professor of Medicine study chair
Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland
Michał Wrzosek, MD principal investigator
Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland
Karina Zatorska, MD, PhD study director
Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland
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 Low-gradient Aortic Stenosis and Aortic Stenosis, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 4 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 2 Dec 2025. 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 Poland. 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 Michał Wrzosek, MD (+48 22 3434189, mwrzosek@ikard.pl), 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 (AUC) describing the sensitivity-specificity relationship of the AI model. (time frame: At the time of the nearest Heart Team meeting following the echocardiographic examination (typically within 1 week).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07144189, which also lists 1 linked publication.
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 2 Dec 2025.