About this trial
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.
Eligibility criteria
Qualifiers
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.)
Disqualifiers
Unavailable or suboptimal quality of the raw data from the ECG signal
Age < 18 years-old
Trial design
Treatments tested in this trial
- Willem AI ECG assessment