Actively Recruiting
Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform
Led by Idoven 1903 S.L. · Updated on 2026-04-13
200000
Participants Needed
4
Research Sites
517 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Unavailable or suboptimal quality of the raw data from the ECG signal
- Age < 18 years-old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
2
La Paz University Hospital
Madrid, Spain, 28046
Not Yet Recruiting
3
Puerta de Hierro University Hospital
Madrid, Spain, 28222
Not Yet Recruiting
4
Murcia University
Murcia, Spain, 30100
Not Yet Recruiting
Research Team
M
Manuel Marina-Breysse, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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