Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Idoven 1903 S.L.
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:
You may not qualify if…
- ✕ Unavailable or suboptimal quality of the raw data from the ECG signal
- ✕ Age \< 18 years-old
Where it's recruiting
Nashville
Source: ClinicalTrials.gov · NCT07333547 · last updated 2026-07-20