MedTrace Logo

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

NCT05890716 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5342

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

AI-powered ECG analysis to detect cardiac arrhythmic episodes

ECG recording and processing by AI platform

Sponsors & Collaborators

  • Fundación de Investigación en Red en Enfermedades Cardiovasculares

    collaborator OTHER

  • Spanish Society of Cardiology

    collaborator OTHER

  • Idoven 1903 S.L.

    lead INDUSTRY

Principal Investigators

  • María De La Parte, MD · Idoven 1903 S.L.

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05890716 on ClinicalTrials.gov