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

NCT ID: NCT07156851

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2040-07-01

Brief Summary

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.

Detailed Description

The BELIEVE registry (BELgian registry of Implanted EV-ICDs to Evaluate parameters and complications) is a multicenter, observational registry designed to gather real-world data on the use of extravascular implantable cardioverter-defibrillators (EV-ICDs) in Belgium. This new generation of ICD technology offers the potential advantages of both subcutaneous (S-ICD) and transvenous (TV-ICD) devices, with the lead placed under the sternum. This position enables pacing capabilities and more accurate arrhythmia detection while aiming to minimize lead-related complications seen in previous ICD systems.

Given the relatively recent introduction of EV-ICDs, it is essential to monitor their performance and clinical outcomes in routine clinical settings. While initial trials have demonstrated feasibility and safety, real-world data are crucial for understanding long-term efficacy, complication rates, therapy effectiveness, device longevity, and overall patient outcomes. The BELIEVE registry was therefore established to support this need, offering a structured framework to follow patients over time and improve clinical practice related to EV-ICDs.

The registry is both retrospective and prospective, non-randomized, and will include all patients in Belgium who undergo (or have undergone) an EV-ICD implantation-regardless of whether the procedure was successful. Participating centers will aim to enroll an initial cohort of 100 patients over a 4-year period, although the number of patients and study duration may be extended. The total planned study period is 15 years, with patients followed throughout the life of their device.

Inclusion criteria are broad: participants must be at least 18 years old, have had or be scheduled for an EV-ICD implantation (even if unsuccessful), and must provide informed consent. Patients who did not undergo any part of the implantation procedure are excluded.

Data will be collected at baseline, during the procedure, and during scheduled follow-up visits (at 1-3 months, 6 months, and then at least annually). Information will include demographic and clinical characteristics, medical history, device data, arrhythmia detection, therapy delivery, programming changes, complications, and patient-reported outcomes.

Conditions

Implantable Cardioverter Defibrillator (ICD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Jan AV

OTHER

Sponsor Role: lead

Responsible Party

Jean-Benoît Le Polain de Waroux

Coordinating Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Emma Christiaen

Role: CONTACT

SM-SJ-Cardiologie-Studies@azsintjan.be

+32 50 45 32 93

Other Identifiers

BELIEVE

Identifier Type: -

Identifier Source: org_study_id