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AI heart reader aims to spot deadly rhythms before It's too late

NCT ID NCT05890716

Diagnosis Sponsor: Idoven 1903 S.L. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This study is testing a cloud-based artificial intelligence platform called Willem that analyzes ECG recordings to detect heart rhythm problems and abnormal patterns. Researchers will compare the AI's readings to those of board-certified cardiologists in over 5,300 high-risk cardiac patients. The goal is to see if the AI can match or exceed human expert accuracy, potentially leading to earlier detection and prevention of serious events like sudden cardiac arrest.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-powered ECG analysis software
What this could lead to
If successful, this AI could help doctors catch dangerous heart rhythms faster and more accurately, potentially preventing heart attacks or sudden cardiac death.
What could go wrong
This is an observational study, not a treatment trial. The AI may not perform as well in real-world settings or on all types of heart patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,342 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients recorded with a mid to long-term ECG device according to guidelines. ECG data (ECG must have been recorded according to the technical standards for the safety and essential performance of medical electrical equipment defined in EN 60601-2-47:2015.): 12-lead ECGs including rest electrocardiograms, stress ECG Test (exercise Electrocardiogram or treadmill test), Holter devices, long-duration Holter devices, event recorders, insertable cardiac monitors, 6,3,2,1-lead ECG wearables, textile electrodes and patches, smartwatches, cardiac monitors, cardiac telemetries, hemodynamic and electrophysiology recording system (i.e., polygraphs), automatic external defibrillator (AED), semi-automatic defibrillator (DESA), home telemonitoring systems and other similar devices.

Ages

4 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome Arrhythmias, Cardiac cardiac arrest cardiac rhythm disease cardiomyopathy coronary artery disorder Death, Sudden, Cardiac heart disorder heart failure sudden arrhythmia death syndrome sudden cardiac arrest ventricular arrhythmias due to cardiac ryanodine receptor calcium release deficiency syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac arrest Cardiac arrhythmias Cardiomyopathies Sudden cardiac death

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clínica Universitaria Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Complejo Hospitalario Universitario A Coruña

    COMPLETED

    A Coruña, La Coruña, 15006, Spain

  • Hospital Clínico San Carlos

    COMPLETED

    Madrid, Madrid, 28040, Spain

  • Hospital General Universitario de Ciudad Real

    COMPLETED

    Ciudad Real, Ciudad Real, 13005, Spain

  • Hospital Sant Joan de Déu

    COMPLETED

    Barcelona, Barcelona, 08950, Spain

  • Hospital Universitario General de Villalba

    COMPLETED

    Madrid, Madrid, 28400, Spain

  • Hospital Universitario Nuestra Señora de Candelaria

    COMPLETED

    Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010, Spain

  • Hospital Universitario Puerta de Hierro

    COMPLETED

    Madrid, Madrid, 28222, Spain

  • Hospital Universitario de Basurto

    RECRUITING

    Bilbao, Vizcaya, 48013, Spain

  • Hospital Universitario del Henares

    COMPLETED

    Madrid, Madrid, 28822, Spain

  • Hospital Universitario y Politécnico La Fe

    COMPLETED

    Valencia, Valencia, 46026, Spain

  • Hospital Virgen de Arrixaca

    COMPLETED

    Murcia, Murcia, 30120, Spain

  • University Medical Center Groningen

    COMPLETED

    Groningen, Provincie Groningen, 9713 GZ, Netherlands

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