RecruitingNCT05890716

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

Evaluation of Electrocardiographic Data From High-risk Cardiac Patients Using Willem™ Cardiologist-level Artificial Intelligence Software. WILLEM Trial.


Sponsor

Idoven 1903 S.L.

Enrollment

5,342 participants

Start Date

Apr 4, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 4 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying AI-powered ECG analysis to detect cardiac arrhythmic episodes for people with cardiac arrest, cardiac arrhythmias, and other related conditions. The study is currently recruiting participants at 14 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTAI-powered ECG analysis to detect cardiac arrhythmic episodes

ECG recording and processing by AI platform


Locations(13)

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Hospital Sant Joan de Déu

Barcelona, Barcelona, Spain

Hospital General Universitario de Ciudad Real

Ciudad Real, Ciudad Real, Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, La Coruña, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Madrid, Spain

Hospital Universitario General de Villalba

Madrid, Madrid, Spain

Hospital Universitario del Henares

Madrid, Madrid, Spain

Hospital Virgen de Arrixaca

Murcia, Murcia, Spain

Clínica Universitaria Navarra

Pamplona, Navarre, Spain

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

Hospital Universitario de Basurto

Bilbao, Vizcaya, Spain

View Full Details on ClinicalTrials.gov

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NCT05890716


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