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Clinical trial Recruiting at 6 sites Observational Ages 18 and up

Belgian registry for extravascular ICDs to track real-world use

Official title: Observational BELgian Registry of Implanted EV-ICD to Evaluate Parameters and Complications of the New Device in Real World Settings

Run by AZ Sint-Jan AV · NCT07156851 · Data updated 2026-11-12

This Belgian registry follows adults with extravascular ICDs to see how the devices perform and what issues arise over time in routine care.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorAZ Sint-Jan AV
Academic / other
Locations7 sites (Antwerp and 6 other locations)
StatusRecruiting
StartedSeptember 25, 2025
Main results expectedJuly 1, 2040
Study endsJuly 1, 2040
Registry record updatedSeptember 15, 2026
Trial IDNCT07156851 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) who have had or will have an EV-ICD implanted and have provided informed consent.

Probably not a fit

Patients who do not undergo EV-ICD implantation or who do not consent may not contribute to the study findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The BELIEVE registry collects real-world data on extravascular ICDs (EV-ICDs) used in Belgium, focusing on device parameters, complications, arrhythmia detection and therapy, and patient outcomes. It is a multicenter observational study that combines retrospective and prospective data without altering standard care. Eligible participants include adults with current or planned EV-ICD implantation, with data gathered from medical records after informed consent. The study aims to enroll about 100 patients over four years to understand long-term performance, safety, and effectiveness of EV-ICDs in everyday practice.

Why it matters

Potential benefit: If successful, the registry could clarify long-term safety and effectiveness of EV-ICDs and inform clinical practice and device development in Belgium.

How similar studies have gone: Preliminary trials have shown feasibility and safety of EV-ICDs; real-world registries like this one help confirm and extend those findings.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • Uza
    Antwerp, Belgium     Recruiting
  • ZAS Middelheim
    Antwerp, Belgium     Recruiting
  • AZ Sint-Jan Brugge
    Bruges, Belgium     Recruiting
  • UCL Saint-Luc
    Brussels, Belgium     Recruiting
  • UZ Brussel
    Brussels, Belgium     Recruiting
  • UZ Gent
    Ghent, Belgium     Recruiting
Show 1 more location
  • CHU Liège
    Liège, Belgium     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.