AI analysis of ECGs for high-risk cardiac patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clínica Universitaria Navarra
  Pamplona, Navarre, Spain Recruiting
• Hospital Universitario de Basurto
  Bilbao, Vizcaya, Spain Recruiting
• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.