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

Study acronym: BELIEVE
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Trial sites expanded: 0 → 7 locations
    • Start date changed from estimate of Nov 2025 to Sep 25, 2025
    • Secondary endpoints: details revised at 1 of 9 entries
    • Eligibility criteria expanded, about 4 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to follow all patients implanted with extravascular implantable cardioverter-defibrillators (EV-ICDs) in Belgium throughout the lifetime of the devices. The main goal of the study is to keep track of: * all parameters of the device * complications * arrhythmia detection and therapy delivery * clinical endpoints (quality of life, cardiac and infectious events) Participants who underwent or will undergo an EV-ICD implantation as part of their regular medical care will be asked if data can be collected from their medical record. No additional tasks are required for the study.
Trial Details
NCT Number NCT07156851
Lead Sponsor AZ Sint-Jan AV
Conditions
(from sponsor)		 Implantable Cardioverter Defibrillator (ICD)
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov