Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Willem AI ECG assessment.
- Who it may be relevant to
- Registry conditions: High-risk Cardiac Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Ecuador, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Patient enrollment will be both retrospective and prospective.
Interventions
- 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.
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Spain · 3 centers
- La Paz University Hospital — Madrid
- Puerta de Hierro University Hospital — Madrid
- Murcia University — Murcia
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Ecuador · 1 center
- CardioHeredia — Guayaquil
Identifiers
NCT: NCT07333547 · WR_01