Recruiting

Willem

Sponsor:

Idoven 1903 S.L.

Code:

NCT07333547

Conditions

High-risk Cardiac Patients

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Willem AI ECG assessment

Study Details

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

Study ID

NCT07333547

Start date

Feb 3, 2026

Status verified date

Jul, 2026

Completion date

Jan, 2036

Anticipated

Primary completion date

Jan, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200000 participants

Anticipated

Interventions and Outcome Measures

Arms

High-risk cardiac patients

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

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

Interventions

Willem AI ECG assessment

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 outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Manuel Marina-Breysse, MD, PhD

+34669752391clinical@idoven.ai

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator:

Evan Brittain

More Information

Sponsor

Idoven 1903 S.L.

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Idoven 1903 S.L. on 2026-07-20.