Implantable Cardioverter Defibrillator (ICD)BELIEVENCT07156851
Observational BELgian Registry of Implanted EV-ICD to Evaluate Parameters and Complications of the New Device in Real World Settings
An observational study of Implantable Cardioverter Defibrillator (ICD), run by AZ Sint-Jan AV at 7 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantable Cardioverter Defibrillator (ICD)
- How many people
- 100 participants
- Where
- 7 sitesBelgium
- Study dates
- 25 Sep 2025to 1 Jul 2040
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent or will undergo an EV-ICD implantation in Belgium, whether successful or not, can be included in this registry.
Who may be able to join
- At least 18 years old
- Previous or planned EV-ICD implantation (successful or not)
- Informed consent signed
Who cannot join
- Patients who did not undergo any step of the implantation procedure
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Belgium7 sites, 7 recruiting
- Recruiting
UZA
Antwerp
Dr. Wim Huybrechts
- Recruiting
ZAS Middelheim
Antwerp
Dr. Michael Wolf
- Recruiting
AZ Sint-Jan Brugge
Bruges
Dr. Nicolas Blankoff, +3250452670, cardiologie@azsintjan.be
- Recruiting
UCL Saint-Luc
Brussels
Dr. Sébastien Marchandise
- Recruiting
UZ Brussel
Brussels
Dr. Ingrid Overeinder
- Recruiting
UZ Gent
Ghent
Dr. Liesbeth Timmers
- Not yet recruiting
CHU Liège
Liège
Dr. Caroline Piette
About this study
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.
Read the 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.
- Keywords
- Extravascular implantable cardioverter-defibrillator, EV-ICD
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of delivered therapies (ATP and shocks)
Total number of therapies delivered by the device, including antitachycardia pacing and shocks (Unit: count)
Measured: Lifetime of the device (up to 15 years)
Proportion of delivered therapies that were appropriate
Percentage of therapies delivered by the device that were adjudicated as appropriate (i.e., delivered for true ventricular arrhythmia).
Measured: Lifetime of the device (up to 15 years)
Proportion of delivered therapies that were successful
Percentage of therapies delivered by the device that successfully terminated the targeted ventricular arrhythmia.
Measured: Lifetime of the device (up to 15 years)
Tracking procedural and device-related complications
Tracking procedural and device-related complications during the lifetime of the device
Measured: Lifetime of the device (up to 15 years)
Secondary outcomes (9)
Change in sensing amplitude over time
Change in device-recorded sensing amplitude (in mV) from implantation to follow-up visits.
Measured: Lifetime of the device (up to 15 years)
Change in pacing threshold over time
Change in pacing threshold (in Volt) measured during device follow-up from implantation to 15 years.
Measured: Lifetime of the device (up to 15 years)
Change in lead impedance over time
Change in lead impedance (in Ohm) from implantation to 15 years of follow-up.
Measured: Lifetime of the device (up to 15 years)
Change in battery longevity estimates over time
Change in estimated battery longevity (in years) as reported by the device at each follow-up visit.
Measured: Lifetime of the device (up to 15 years)
Accuracy of arrhythmia detection by the device
Proportion of arrhythmia episodes correctly classified by the device (%)
Measured: Lifetime of the device (up to 15 years)
Summary of device reprogramming
Summary of every device reprogramming including reason for changes
Measured: Lifetime of the device (up to 15 years)
Number of participants with major adverse cardiac events (MACE)
Number of participants experiencing major adverse cardiac events, including cardiovascular death, hospitalization for heart failure, myocardial infarction, or stroke.
Measured: Lifetime of the device (up to 15 years)
Number of participants with device-related infections
Number of participants with infections requiring antibiotic treatment or device/system extraction.
Measured: Lifetime of the device (up to 15 years)
Number of participants reporting device-related complaints
Number of participants reporting device-related symptoms or complaints (e.g., inappropriate shocks, pain at device site).
Measured: Lifetime of the device (up to 15 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start25 Sep 2025
- Primary completion1 Jul 2040 (estimated)
- Study completion1 Jul 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implantable Cardioverter Defibrillator (ICD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Benoît Le Polain de Waroux, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156851
- Sponsor's protocol ID
- BELIEVE
- Acronym
- BELIEVE
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational BELgian Registry of Implanted EV-ICD to Evaluate Parameters and Complications of the New Device in Real World Settings
- ClinicalTrials.gov ID
- NCT07156851
- Acronym / sponsor ID
- BELIEVE / BELIEVE
- Keywords
- Extravascular implantable cardioverter-defibrillator, EV-ICD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 1 Jul 2040 (estimated)
- Study completion
- 1 Jul 2040 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent or will undergo an EV-ICD implantation in Belgium, whether successful or not, can be included in this registry.
Key inclusion criteria (3 listed)
- At least 18 years old
- Previous or planned EV-ICD implantation (successful or not)
- Informed consent signed
Key exclusion criteria (1 listed)
- Patients who did not undergo any step of the implantation procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of delivered therapies (ATP and shocks)
Time frame: Lifetime of the device (up to 15 years)
Total number of therapies delivered by the device, including antitachycardia pacing and shocks (Unit: count)
Proportion of delivered therapies that were appropriate
Time frame: Lifetime of the device (up to 15 years)
Percentage of therapies delivered by the device that were adjudicated as appropriate (i.e., delivered for true ventricular arrhythmia).
Proportion of delivered therapies that were successful
Time frame: Lifetime of the device (up to 15 years)
Percentage of therapies delivered by the device that successfully terminated the targeted ventricular arrhythmia.
Tracking procedural and device-related complications
Time frame: Lifetime of the device (up to 15 years)
Tracking procedural and device-related complications during the lifetime of the device
9 secondary outcomes
Change in sensing amplitude over time
Time frame: Lifetime of the device (up to 15 years)
Change in pacing threshold over time
Time frame: Lifetime of the device (up to 15 years)
Change in lead impedance over time
Time frame: Lifetime of the device (up to 15 years)
Change in battery longevity estimates over time
Time frame: Lifetime of the device (up to 15 years)
Accuracy of arrhythmia detection by the device
Time frame: Lifetime of the device (up to 15 years)
Summary of device reprogramming
Time frame: Lifetime of the device (up to 15 years)
Number of participants with major adverse cardiac events (MACE)
Time frame: Lifetime of the device (up to 15 years)
Number of participants with device-related infections
Time frame: Lifetime of the device (up to 15 years)
Number of participants reporting device-related complaints
Time frame: Lifetime of the device (up to 15 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implantable Cardioverter Defibrillator (ICD), run by AZ Sint-Jan AV at 7 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Christiaen (+32 50 45 32 93, SM-SJ-Cardiologie-Studies@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of delivered therapies (ATP and shocks) (time frame: Lifetime of the device (up to 15 years)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.