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

NCT07333547 | Recruiting FDA Device

• 1 other identifier: WR_01
• Study Type: observational
• Target: 200,000
• Locations: 2 countries
• Sites: 4

Brief 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. 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.

Conditions

High-risk Cardiac Patients

Keywords

artificial intelligence; electrocardiogram; deep learning; cardiac disease; registry

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

High-risk cardiac patients

High-risk cardiac patients undergoing routine care electrocardiogram (ECG) for assessment of arrhythmias or cardiac diseases

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

Device: Willem AI ECG assessment

Interventions

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.

Controls; High-risk cardiac patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Idoven 1903 S.L.: lead

Study Sites (4)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

La Paz University Hospital

Madrid, 28046, Spain

NOT YET RECRUITING

Puerta de Hierro University Hospital

Madrid, 28222, Spain

NOT YET RECRUITING

Murcia University

Murcia, 30100, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Manuel Marina-Breysse, MD, PhD

CONTACT

+34669752391; clinical@idoven.ai

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036
• Last Updated: April 13, 2026

Record last verified: 2025-12

Locations

ES (3); US (1)