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

Launched by IDOVEN 1903 S.L. · May 26, 2023

Keywords

ClinConnect Summary

The WILLEM clinical trial is studying a new technology called Willem™, which uses artificial intelligence (AI) to analyze heart activity through electrocardiograms (ECGs). This study aims to see if Willem™ can accurately identify dangerous heart rhythm problems (known as arrhythmias) and predict when they might happen. The main goal is to help doctors make better decisions about treatment, potentially preventing serious issues like sudden cardiac death or the need for harmful therapies.

To participate in this study, patients should have a history of heart rhythm problems or abnormal ECG results and must have at least one ECG recording that can be analyzed. They should also be dealing with heart-related conditions such as heart failure, cardiomyopathies, or have devices like pacemakers. Participants will undergo careful monitoring, and their ECG data will be reviewed by specialized heart doctors. If you or a loved one are interested, you'll need to give your consent to join the study, and if you can't, an authorized family member can help with that. This study is currently recruiting patients of all ages who meet the criteria, and it promises to contribute to better heart health for those at high risk.

Gender

ALL

Eligibility 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.