Actively Recruiting

Age: 4Years +
All Genders
Healthy Volunteers
NCT05890716

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

Age: 4Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here