High-risk Cardiac PatientsWILLEMRegistryNCT07333547
Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform
An observational study of High-risk Cardiac Patients, run by Idoven 1903 S.L. at 5 sites in 3 countries.
Trial summary
The WILLEM Registry is a large-scale, single-group, observational, registry study to collect continuous clinical evidence of Willem in real-world settings. Cardiovascular diseases are a major problem for public health and healthcare systems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- High-risk Cardiac Patients
- What is being tested?
- Willem AI ECG assessment
- Type of treatment
- Medical device
- How many people
- 200,000 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 3 Feb 2026to Jan 2036
- Phase
- Observational
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: Subjects with high-risk and/or high-cost cardiac disease undergoing standard of care ECG assessment during the screening or diagnostic process, complementary tests, interventions, and/or clinical follow-up visits in any setup of care. Additionally, for the assessment of cardiac disease detection, subjects with no cardiac risk may be recruited as well for comparison between confirmed diagnosed patients and confirmed negative diagnosed subjects.
Who may be able to join
- EC/IRB approval of ICF waiver prior to recruitment; otherwise, signed informed consent form by subject and investigator
- Age > 18 years-old, with no upper limit
- Subjects undergoing standard of care electrocardiogram (ECG) of any duration from any hardware device
- All available, but at least one, legible ECG tracings in raw data format (e.g. DICOM, XML, EDF, JSON, HL7, SCP, WFDB, CSV, etc.)
- Available subject clinical data associated with the ECG
- For 12-lead ECGs, a minimum length of 10 seconds at a minimum sample frequency of 250 Hz
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- For ECGs from Holters, wearables, patches, insertable cardiac monitors, telemetries, etc., a minimum length of 30 seconds at a minimum sample frequency of 200 Hz with a lead I / II or its MCL-DII lead approximation
- For prospective eligibility only:
- Signed informed consent form, unless previously waived by the EC/IRB
- Site technical viability for ECG and subject clinical data transfer (e.g. end-to-end integration following interoperability standards such as FHIR, HL7 or DICOM)
Who cannot join
- Unavailable or suboptimal quality of the raw data from the ECG signal
- Age < 18 years-old
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
Spain3 sites, 3 recruiting
- Not yet recruiting
La Paz University Hospital
Madrid, 28046
Teresa López Fernández, MD, PhD
Teresa López Fernández
- Recruiting
Puerta de Hierro University Hospital
Madrid, 28222
Pablo García Pavía, MD, PhD
Pablo García Pavía
- Not yet recruiting
Murcia University
Murcia, 30100
Sergio Manzano Fernández, MD, PhD
Sergio Manzano Fernández
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Evan Brittain, MD, MSCI
Evan Brittain
Ecuador1 site, 1 recruiting
- Recruiting
CardioHeredia
Guayaquil, Guayas, 090101 - 090158
Cinthia Madrid
Fausto Heredia
About this study
The WILLEM Registry is a large-scale, single-group, observational, registry study to collect continuous clinical evidence of Willem in real-world settings. Cardiovascular diseases are a major problem for public health and healthcare systems. Electrocardiograms (ECGs) are simple tests which increase diagnostic performance and early detection of cardiovascular diseases. However, its interpretation is complex, time consuming for cardiology experts, and entails high costs for healthcare systems. Willem allows AI-based automatic interpretation and its performance has been examined in previous clinical trials, but additional clinical evidence is needed for its integration in real-world clinical settings. This study will collect clinical evidence of Willem performance to detect cardiac abnormalities in ECGs from high-risk cardiac patients admitted to cardiovascular units.
Read the detailed description
Patient enrollment will be both retrospective and prospective.
- Conditions
- High-risk Cardiac Patients
- Being tested
- Willem AI ECG assessment
- Keywords
- artificial intelligence, electrocardiogram, deep learning, cardiac disease, registry
- Medical subject headings
- 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 ECGs for the identification of cardiac patterns, arrhythmias, and/or cardiac diseases. 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 |
|---|---|---|
| High-risk cardiac patients | High-risk cardiac patients undergoing routine care electrocardiogram (ECG) for assessment of arrhythmias or cardiac diseases Receives: Device: Willem AI ECG assessment | |
| Controls | In case of any cardiac disease diagnosed to the high-risk cardiac patient cohort, controls will be any enrolled patient with no confirmed diagnosis of such cardiac disease Receives: Device: Willem AI ECG assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint analysis: Willem performance
ECG data will be categorized according to SOC-defined cardiopathies, arrhythmic events, and cardiac diseases. If SOC diagnosis is unavailable or inconsistent, an independent committee of expert cardiologists will review and provide their diagnosis according to a cardiac defined ontology which extends values defined in HL7-aECG data store. Then, the performance of Willem to detect cardiac patterns, arrhythmias, and cardiac disease from ECGs will be assessed. In order to define True Positive, True Negative, False Positive, and False Negative classifications, the ground truth for comparison will be Standard Of Care (SOC) manually performed cardiologist diagnosis.
Performance metrics such as diagnostic accuracy, sensitivity, specificity, predictive positive value (PPV), negative predictive value (NPV), F1-Score and Area Under the Receiver Operating Characteristic Curve (AUROC) will be obtained.
Measured: From enrollment to any standard of care timepoint when the patient underwent (retrospective) or will undergo within the next 10 years (prospective) an eligible electrocardiogram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start3 Feb 2026
- Primary completionJan 2036 (estimated)
- Study completionJan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Cardiac PatientsStudies 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
- 200,000 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
- NCT07333547
- Sponsor's protocol ID
- WR_01
- Acronym
- WILLEMRegistry
- Status last verified
- Jul 2026
- First submitted
- 30 Dec 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided