Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform
Idoven 1903 S.L.
Summary
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.
Description
Patient enrollment will be both retrospective and prospective.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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, weara…
Interventions
- DeviceWillem 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.
Locations (4)
- Vanderbilt University Medical CenterNashville, Tennessee
- La Paz University HospitalMadrid
- Puerta de Hierro University HospitalMadrid
- Murcia UniversityMurcia