Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform

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)