Actively Recruiting
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Led by Idoven 1903 S.L. · Updated on 2026-04-03
5342
Participants Needed
14
Research Sites
186 weeks
Total Duration
On this page
Sponsors
I
Idoven 1903 S.L.
Lead Sponsor
F
Fundación de Investigación en Red en Enfermedades Cardiovasculares
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient presenting relevant cardiac arrhythmias and cardiac patterns recorded with at least one short-term ECG device with 1 signal-channel
- Patient with suspected or diagnosed acute or chronic cardiac diseases including heart failure, history of arrhythmias, coronary artery diseases, cardiomyopathies, pacemakers or ICDs, or indication for these devices
- Patient with at least one ECG tracing exportable in raw data
- Signed informed consent obtained, or consent from authorized relative if patient unable
You will not qualify if you...
- Unwillingness or inability to sign written informed consent
- Electrocardiographic signal unavailable or of suboptimal quality in raw data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9713 GZ
Completed
2
Hospital Sant Joan de Déu
Barcelona, Barcelona, Spain, 08950
Completed
3
Hospital General Universitario de Ciudad Real
Ciudad Real, Ciudad Real, Spain, 13005
Completed
4
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain, 15006
Completed
5
Idoven 1903 S.L.
Madrid, Madrid, Spain, 28002
Actively Recruiting
6
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040
Completed
7
Hospital Universitario Puerta de Hierro
Madrid, Madrid, Spain, 28222
Actively Recruiting
8
Hospital Universitario General de Villalba
Madrid, Madrid, Spain, 28400
Completed
9
Hospital Universitario del Henares
Madrid, Madrid, Spain, 28822
Completed
10
Hospital Virgen de Arrixaca
Murcia, Murcia, Spain, 30120
Completed
11
Clínica Universitaria Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
12
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain, 38010
Actively Recruiting
13
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain, 46026
Completed
14
Hospital Universitario de Basurto
Bilbao, Vizcaya, Spain, 48013
Actively Recruiting
Research Team
M
Manuel Marina-Breysse, MSc, MD
CONTACT
J
José María Lillo, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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