Aortic StenosisAoS-SEDAINCT07479992
Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study
An observational study of Aortic Stenosis, run by Idoven 1903 S.L. at 2 sites in Germany.
Trial summary
AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study. This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients from 12-lead electrocardiogram (ECG) data. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Willem AI ECG assessment
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 2 sitesGermany
- Study dates
- 28 Apr 2026to Feb 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population consists of patients under assessment of Aortic Stenosis (AS). Screened patients need to have 12-lead ECG recordings within 90 days of a transthoracic echocardiogram (TTE). In the case of multiple ECGs and TTEs per patient, all of them will be selected and analysed accordingly considering the corresponding PI diagnosis at each time. In the event of a patient with a different diagnosis over time (e.g. non-AS confirmed diagnosis later on diagnosed with AS), multiple timepoint ECGs will be categorized so that the same patient is not included both in the control and in the AS populations. Controls will include non-AS patients with relevant TTE and clinical findings during AS differential diagnosis (such as hypertensive heart disease, structural heart diseases, hypertrophic cardiomyopathy among other cardiomyopathies, mild aortic stenosis, and no significant aortic leaflet calcification).
Who may be able to join
- Age ≥ 18 years;
- All available 12-lead ECG with a 10 seconds minimum length on raw data digital format will be included
- Available clinical data corresponding to each ECG to confirm patient demographics and Aortic Stenosis diagnosis
- Available transthoracic echocardiogram (TTE) within +/- 90 days of each ECG recording
- No exclusion criteria are defined for this study.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Bonn
Bonn
Sebastian Zimmer, MD, PhD
- Recruiting
Technical University of Munich
Munich
Tobias Rheude, MD, PhD
About this study
Official title: Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram (Willem AoS-SEDAI) Study
AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study.
This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients from 12-lead electrocardiogram (ECG) data.
Read the detailed description
Aortic Stenosis (AS) is a common and progressive valvular heart disease, especially in older adults, yet significantly underdiagnosed. Many individuals with significant AS may remain asymptomatic for extended periods or experience vague symptoms, delaying diagnosis for several years. In some cases, sudden cardiac events or decompensation may be the first indication of advanced AS, particularly in those who have not undergone regular cardiovascular evaluation.
The primary method for diagnosing AS is echocardiography, which allows visualization of valve anatomy and assessment of transvalvular gradients. However, reliance on symptom reporting or late-stage signs, that trigger a provider to order an echo, can result in missed opportunities for earlier detection. Additionally, electrocardiographic changes-such as left ventricular hypertrophy or strain patterns-can often be detected before structural abnormalities are visible on imaging studies. This delay between electrical changes evolution and later structural findings creates a valuable opportunity to intervene sooner, for example with a valve replacement. This diagnostic latency highlights a critical window where early identification through Artificial Intelligence (AI) analysis of electrocardiograms (ECGs) and timely referral to cardiology can significantly alter disease trajectory and improve outcomes, especially in primary care and community health settings.
AoS-SEDAI study is an observational, retrospective and prospective, multicenter clinical study. Even though controls will be distinguished from AS patients for ground truth and performance evaluation, this is a single-arm study since there are no differences in study interventions.
- Conditions
- Aortic Stenosis
- Being tested
- Willem AI ECG assessment
- Keywords
- artificial intelligence, electrocardiogram, deep learning, cardiac disease, aortic stenosis
- Medical subject headings
- Aortic Valve Stenosis, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Willem AI ECG assessmentDevice
There is no study intervention. The Willem AI platform will assess all study electrocardiograms (ECGs) for the identification of aortic stenosis. Regardless of retrospective or prospective enrollment, Willem output will not be provided to the healthcare professional user for clinical evaluation, and therefore routine practice will not be impacted nor altered.
| Study group | Role | What they receive |
|---|---|---|
| Aortic Stenosis patients | Subjects with an Aortic Stenosis diagnosis confirmed by the physician following their routine practice (e.g. ESC Guidelines), including complete clinical assessment with echocardiogram or other complementary techniques. Receives: Device: Willem AI ECG assessment | |
| Non-Aortic Stenosis patients (Controls) | Subjects without Aortic Stenosis confirmed by the physician after thorough evaluation following their routine practice. Receives: Device: Willem AI ECG assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willem performance to detect severe Aortic Stenosis
Performance of Willem AI platform to distinguish between severe Aortic Stenosis (AS) patients with confirmed diagnosis and non-AS patients, by means of the following performance metrics: Area Under the Receiver Operating Characteristic curve (AUROC), diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
The Standard Of Care (SOC) investigator diagnosis will be used as the ground truth.
Measured: ECG will be performed at baseline, and ECG analysis by Willem AI will be performed retrospectively throughout the trial, and finalized upon recruitment completion.
Secondary outcomes (1)
Willem performance to detect moderate Aortic Stenosis
Performance of Willem AI platform to distinguish between moderate Aortic Stenosis (AS) patients with confirmed diagnosis and non-AS patients, by means of the following performance metrics: Area Under the Receiver Operating Characteristic curve (AUROC), diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). The Standard Of Care (SOC) investigator diagnosis will be used as the ground truth.
Measured: ECG will be performed at baseline, and ECG analysis by Willem AI will be performed retrospectively throughout the trial, and finalized upon recruitment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start28 Apr 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Idoven 1903 S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479992
- Sponsor's protocol ID
- AoS-SEDAI_01
- Acronym
- AoS-SEDAI
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2026
- Last updated
- 4 Nov 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram (Willem AoS-SEDAI) Study
- ClinicalTrials.gov ID
- NCT07479992
- Acronym / sponsor ID
- AoS-SEDAI / AoS-SEDAI_01
- Conditions
- Aortic Stenosis
- Keywords
- artificial intelligence, electrocardiogram, deep learning, cardiac disease, aortic stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Idoven 1903 S.L.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 18 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.
AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study.
This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients from 12-lead electrocardiogram (ECG) data.
Detailed description
Aortic Stenosis (AS) is a common and progressive valvular heart disease, especially in older adults, yet significantly underdiagnosed. Many individuals with significant AS may remain asymptomatic for extended periods or experience vague symptoms, delaying diagnosis for several years. In some cases, sudden cardiac events or decompensation may be the first indication of advanced AS, particularly in those who have not undergone regular cardiovascular evaluation.
The primary method for diagnosing AS is echocardiography, which allows visualization of valve anatomy and assessment of transvalvular gradients. However, reliance on symptom reporting or late-stage signs, that trigger a provider to order an echo, can result in missed opportunities for earlier detection. Additionally, electrocardiographic changes-such as left ventricular hypertrophy or strain patterns-can often be detected before structural abnormalities are visible on imaging studies. This delay between electrical changes evolution and later structural findings creates a valuable opportunity to intervene sooner, for example with a valve replacement. This diagnostic latency highlights a critical window where early identification through Artificial Intelligence (AI) analysis of electrocardiograms (ECGs) and timely referral to cardiology can significantly alter disease trajectory and improve outcomes, especially in primary care and community health settings.
AoS-SEDAI study is an observational, retrospective and prospective, multicenter clinical study. Even though controls will be distinguished from AS patients for ground truth and performance evaluation, this is a single-arm study since there are no differences in study interventions.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aortic Stenosis patients | – | Device: Willem AI ECG assessmentSubjects with an Aortic Stenosis diagnosis confirmed by the physician following their routine practice (e.g. ESC Guidelines), including complete clinical assessment with echocardiogram or other complementary techniques. |
| Non-Aortic Stenosis patients (Controls) | – | Device: Willem AI ECG assessmentSubjects without Aortic Stenosis confirmed by the physician after thorough evaluation following their routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population consists of patients under assessment of Aortic Stenosis (AS). Screened patients need to have 12-lead ECG recordings within 90 days of a transthoracic echocardiogram (TTE). In the case of multiple ECGs and TTEs per patient, all of them will be selected and analysed accordingly considering the corresponding PI diagnosis at each time. In the event of a patient with a different diagnosis over time (e.g. non-AS confirmed diagnosis later on diagnosed with AS), multiple timepoint ECGs will be categorized so that the same patient is not included both in the control and in the AS populations. Controls will include non-AS patients with relevant TTE and clinical findings during AS differential diagnosis (such as hypertensive heart disease, structural heart diseases, hypertrophic cardiomyopathy among other cardiomyopathies, mild aortic stenosis, and no significant aortic leaflet calcification).
Key inclusion criteria (5 listed)
- Age ≥ 18 years;
- All available 12-lead ECG with a 10 seconds minimum length on raw data digital format will be included
- Available clinical data corresponding to each ECG to confirm patient demographics and Aortic Stenosis diagnosis
- Available transthoracic echocardiogram (TTE) within +/- 90 days of each ECG recording
- No exclusion criteria are defined for this study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Willem AI ECG assessmentThere is no study intervention. The Willem AI platform will assess all study electrocardiograms (ECGs) for the identification of aortic stenosis. Regardless of retrospective or prospective enrollment, Willem output will not be provided to the healthcare professional user for clinical evaluation, and therefore routine practice will not be impacted nor altered. | Device | Aortic Stenosis patients, Non-Aortic Stenosis patients (Controls) |
Primary outcome
Willem performance to detect severe Aortic Stenosis
Time frame: ECG will be performed at baseline, and ECG analysis by Willem AI will be performed retrospectively throughout the trial, and finalized upon recruitment completion.
Performance of Willem AI platform to distinguish between severe Aortic Stenosis (AS) patients with confirmed diagnosis and non-AS patients, by means of the following performance metrics: Area Under the Receiver Operating Characteristic curve (AUROC), diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). The Standard Of Care (SOC) investigator diagnosis will be used as the ground truth.
1 secondary outcome
Willem performance to detect moderate Aortic Stenosis
Time frame: ECG will be performed at baseline, and ECG analysis by Willem AI will be performed retrospectively throughout the trial, and finalized upon recruitment completion.
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 4 Nov 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Idoven 1903 S.L. at 2 sites in Germany.
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 5 inclusion and 0 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 Manuel Marina-Breysse, MD, PhD (+34669752391, clinical@idoven.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willem performance to detect severe Aortic Stenosis (time frame: ECG will be performed at baseline, and ECG analysis by Willem AI will be performed retrospectively throughout the trial, and finalized upon recruitment completion.). 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 4 Nov 2026.