AI analysis of ECGs for high-risk cardiac patients
Evaluation of Electrocardiographic Data From High-risk Cardiac Patients Using Willem™ Cardiologist-level Artificial Intelligence Software. WILLEM Trial.
This study is testing an AI tool that analyzes heart rhythm patterns in high-risk heart patients to see if it can help doctors catch problems earlier and improve patient care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5342 (estimated) |
| Ages | 4 Years and up |
| Sex | All |
| Sponsor | Idoven 1903 S.L. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 14 sites (Groningen, Provincie Groningen and 13 other locations) |
| Trial ID | NCT05890716 on ClinicalTrials.gov |
What this trial studies
The WILLEM study is a multicenter observational trial that evaluates an AI-powered ECG analysis platform called Willem™ designed to detect arrhythmias and other abnormal cardiac patterns in high-risk cardiac patients. It aims to automate the classification and prediction of cardiac arrhythmic episodes, potentially delaying or avoiding harmful therapies and severe cardiac events. Patients will be divided into training and test groups to assess the performance of the AI model against expert cardiologist diagnoses, using data collected from various ECG devices. The study will include a follow-up period of over one year to analyze clinical outcomes and model accuracy.
Who should consider this trial
Good fit: Ideal candidates include patients with suspected or diagnosed cardiac arrhythmias or chronic cardiac diseases who have recorded ECG data.
Not a fit: Patients with acute coronary syndromes, hemodynamic instability, or those undergoing chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of cardiac arrhythmias, reducing the risk of sudden cardiac death.
How similar studies have performed: Other studies have shown promise in using AI for ECG analysis, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient presenting relevant cardiac arrhythmias and cardiac patterns (including supraventricular tachycardias, abnormal ECG patterns, ventricular tachycardias, ventricular fibrillation, pulseless electrical activity or asystole among others) that have been recorded with at least one short-term ECG medical device according to guidelines with ≥1 signal-channel. * Patient with suspected or diagnosed acute/chronic cardiac diseases (including patients with heart failure, patients with history of cardiac arrhythmias, patients with probable coronary artery diseases, patients with cardiomyopathies, patients with pacemakers or implantable cardioverter-defibrillators (ICD), patients with indication of pacemaker or ICD in current or short-term phase, patients participating in other interventional clinical investigation, patients with hemodynamic instability or acute coronary syndromes, pregnant patients, patients with cancer and chemotherapy, patients with life-expectancy lower than 24 months, patients with in or out-of-hospital cardiac arrest with ventricular fibrillation as first documented rhythm). * At least one ECG tracing that can be exported in raw data. * Signed informed consent. Patients unable to consent, it will be requested to an authorized relative. Exclusion Criteria: * Unwillingness or inability to sign study written informed consent. * Unavailable or suboptimal quality of the electrocardiographic signal in raw data.
Where this trial is running
Groningen, Provincie Groningen and 13 other locations
- University Medical Center Groningen — Groningen, Provincie Groningen, Netherlands (Completed)
- Hospital Sant Joan de Déu — Barcelona, Barcelona, Spain (Completed)
- Hospital General Universitario de Ciudad Real — Ciudad Real, Ciudad Real, Spain (Completed)
- Complejo Hospitalario Universitario A Coruña — A Coruña, La Coruña, Spain (Completed)
- Idoven 1903 S.L. — Madrid, Madrid, Spain (Recruiting)
- Hospital Clínico San Carlos — Madrid, Madrid, Spain (Completed)
- Hospital Universitario Puerta de Hierro — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario General de Villalba — Madrid, Madrid, Spain (Completed)
- Hospital Universitario del Henares — Madrid, Madrid, Spain (Completed)
- Hospital Virgen de Arrixaca — Murcia, Murcia, Spain (Completed)
- Clínica Universitaria Navarra — Pamplona, Navarre, Spain (Recruiting)
- Hospital Universitario Nuestra Señora de Candelaria — Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain (Recruiting)
- Hospital Universitario y Politécnico La Fe — Valencia, Valencia, Spain (Completed)
- Hospital Universitario de Basurto — Bilbao, Vizcaya, Spain (Recruiting)
Study contacts
- Principal investigator: María De La Parte, MD — Idoven 1903 S.L.
- Study coordinator: Manuel Marina-Breysse, MSc, MD
- Email: manuel.marina@idoven.ai
- Phone: +34618103160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.