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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
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
    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 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
    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.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Evan Brittain, MD, MSCI

More Details

Status
Recruiting
Sponsor
Idoven 1903 S.L.

Study Contact

Manuel Marina-Breysse, MD, PhD
+34669752391
clinical@idoven.ai

Detailed Description

Patient enrollment will be both retrospective and prospective.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.