Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform

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.

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Key information

Conditions

High-risk Cardiac Patients Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CardioHeredia, Guayaquil, Guayas, Ecuador

About this study

Patient enrollment will be both retrospective and prospective.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
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)

Exclusion criteria

Unavailable or suboptimal quality of the raw data from the ECG signal
Age < 18 years-old

Treatment and study plan

Willem AI ECG assessment

Device

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.

Primary outcomes

Primary endpoint analysis: Willem performance

Time frame: 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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Manuel Marina-Breysse, MD, PhD

CONTACT

[email protected]

+34669752391

Sponsors and collaborators

Lead sponsor

Idoven 1903 S.L.

Industry

Registry information

Acronym: WILLEMRegistry

Important dates

Study start: 2026
Primary completion: 2036
Study completion: 2036
First posted: Jan 12, 2026
Registry last updated: Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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