AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)

WILLEM is a multi-center, prospective and retrospective cohort study. The study will assess the performance of a cloud-based and AI-powered ECG analysis platform, named Willem™, developed to detect arrhythmias and other abnormal cardiac patterns. The main questions it aims to answer are: 1. A new AI-powered ECG analysis platform can automatice the classification and prediction of cardiac arrhythmic episodes at a cardiologist level. 2. This AI-powered ECG analysis can delay or even avoid harmful therapies and severe cardiac adverse events such as sudden death. The prerequisites for inclusion of patients will be the availability of at least one ECG record in raw data, along with patient clinical data and evolution data after more than 1-year follow-up. Cardiac electrical signals from multiple medical devices will be collected by cardiology experts after obtaining the informed consent. Every cardiac electrical signal from every subject will be reviewed by a board-certified cardiologist to label the arrhythmias and patterns recorded in those tracings. In order to obtain tracings of relevant information, \>95% of the subjects enrolled will have rhythm disorders or abnormal ECG's patterns at the time of enrollment.

NCT Number	NCT05890716
Lead Sponsor	Idoven 1903 S.L. Collaborators: Fundación de Investigación en Red en Enfermedades Cardiovasculares, Spanish Society of Cardiology
Conditions	Cardiomyopathies, Cardiac Arrest, Cardiac Arrhythmias, Sudden Cardiac Death
Enrollment	5,342 participants
Start Date	2023-04-04
Primary Completion	2026-11 (estimated)
Study Completion	2026-11 (estimated)
Updated on ClinicalTrials.gov	2026-07-20