NCT05890716 AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
| NCT ID | NCT05890716 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Idoven 1903 S.L. |
| Condition | Cardiomyopathies |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,342 participants |
| Start Date | 2023-04-04 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,342 participants in total. It began in 2023-04-04 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
María De La Parte, MD
PRINCIPAL INVESTIGATOR
Idoven 1903 S.L.
Frequently Asked Questions
Who can join the NCT05890716 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, studying Cardiomyopathies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05890716 currently recruiting?
Yes, NCT05890716 is actively recruiting participants. Contact the research team at manuel.marina@idoven.ai for enrollment information.
Where is the NCT05890716 trial being conducted?
This trial is being conducted at Groningen, Netherlands, Barcelona, Spain, Ciudad Real, Spain, A Coruña, Spain and 9 additional locations.
Who is sponsoring the NCT05890716 clinical trial?
NCT05890716 is sponsored by Idoven 1903 S.L.. The principal investigator is María De La Parte, MD at Idoven 1903 S.L.. The trial plans to enroll 5,342 participants.