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AI heart scanner put to the test on 200,000 patients

NCT ID NCT07333547

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This registry study will enroll 200,000 high-risk cardiac patients to see how well an AI platform called Willem can detect heart problems from standard ECGs. The AI's readings will be compared to expert cardiologist diagnoses, but the AI results won't be shared with doctors, so patient care stays the same. The goal is to gather evidence on whether AI can reliably interpret ECGs in real-world hospital settings.

What this could mean

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

What this could lead to
If successful, this could show that AI can reliably read ECGs, potentially helping doctors spot heart issues faster and more accurately in the future.
What could go wrong
This is an observational study, not a treatment trial. The AI results are not used in patient care, so any benefit is still theoretical. The large size may reveal limitations in real-world accuracy.

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 200,000 people

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

Started

Feb 2026

Expected to finish

Jan 2036

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

Subjects with high-risk and/or high-cost cardiac disease undergoing standard of care ECG assessment during the screening or diagnostic process, complementary tests, interventions, and/or clinical follow-up visits in any setup of care. Additionally, for the assessment of cardiac disease detection, subjects with no cardiac risk may be recruited as well for comparison between confirmed diagnosed patients and confirmed negative diagnosed subjects.

Ages

18 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: * EC/IRB approval of ICF waiver prior to recruitment; otherwise, signed informed consent form by subject and investigator * Age \> 18 years-old, with no upper limit * Subjects undergoing standard of care electrocardiogram (ECG) of any duration from any hardware device * All available, but at least one, legible ECG tracings in raw data format (e.g. DICOM, XML, EDF, JSON, HL7, SCP, WFDB, CSV, etc.) * Available subject clinical data associated with the ECG * For 12-lead ECGs, a minimum length of 10 seconds at a minimum sample frequency of 250 Hz * For ECGs from Holters, wearables, patches, insertable cardiac monitors, telemetries, etc., a minimum length of 30 seconds at a minimum sample frequency of 200 Hz with a lead I / II or its MCL-DII lead approximation * For prospective eligibility only: * Signed informed consent form, unless previously waived by the EC/IRB * Site technical viability for ECG and subject clinical data transfer (e.g. end-to-end integration following interoperability standards such as FHIR, HL7 or DICOM) Exclusion Criteria: * Unavailable or suboptimal quality of the raw data from the ECG signal * Age \< 18 years-old

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart disorder

As listed by the trial registrant

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

High-risk cardiac patients

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites in 3 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • CardioHeredia

    RECRUITING

    Guayaquil, Guayas, 090101 - 090158, Ecuador

  • La Paz University Hospital

    NOT_YET_RECRUITING

    Madrid, 28046, Spain

  • Murcia University

    NOT_YET_RECRUITING

    Murcia, 30100, Spain

  • Puerta de Hierro University Hospital

    RECRUITING

    Madrid, 28222, Spain

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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