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New heart device under watch: belgian study monitors EV-ICD performance

NCT ID NCT07156851

Knowledge-focused Sponsor: AZ Sint-Jan AV 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This observational study will follow 100 patients in Belgium who have received an extravascular implantable cardioverter-defibrillator (EV-ICD) as part of their routine care. Researchers will collect data from medical records on device performance, complications, and patient outcomes over the device's lifetime. No extra tests or visits are required for participants.

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 registry will provide real-world data on how well the EV-ICD works and its safety, helping doctors improve care for patients needing defibrillators.
What could go wrong
This is an observational study, not a treatment trial. It only collects data, so it won't directly improve patient outcomes. Results depend on consistent follow-up over many years.

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 100 people

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

Started

Sep 2025

Expected to finish

Jul 2040

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

All patients who underwent or will undergo an EV-ICD implantation in Belgium, whether successful or not, can be included in this registry.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * At least 18 years old * Previous or planned EV-ICD implantation (successful or not) * Informed consent signed Exclusion Criteria: * Patients who did not undergo any step of the implantation procedure

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As listed by the trial registrant

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

Implantable cardioverter defibrillator (ICD)

How to take part

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

  1. The places running it

    7 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

  • AZ Sint-Jan Brugge

    RECRUITING

    Bruges, Belgium

  • CHU Liège

    NOT_YET_RECRUITING

    Liège, Belgium

  • UCL Saint-Luc

    RECRUITING

    Brussels, Belgium

  • UZ Brussel

    RECRUITING

    Brussels, Belgium

  • UZ Gent

    RECRUITING

    Ghent, Belgium

  • UZA

    RECRUITING

    Antwerp, Belgium

  • ZAS Middelheim

    RECRUITING

    Antwerp, Belgium

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