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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Implantable Cardioverter Defibrillator (ICD)

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Emma Christiaen; Phone Number: +32 50 45 32 93; Email: SM-SJ-Cardiologie-Studies@azsintjan.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of delivered therapies (ATP and shocks)	Total number of therapies delivered by the device, including antitachycardia pacing and shocks (Unit: count)	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).	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.	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	Lifetime of the device (up to 15 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sensing amplitude over time	Change in device-recorded sensing amplitude (in mV) from implantation to follow-up visits.	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.	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.	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.	Lifetime of the device (up to 15 years)
Accuracy of arrhythmia detection by the device	Proportion of arrhythmia episodes correctly classified by the device (%)	Lifetime of the device (up to 15 years)
Summary of device reprogramming	Summary of every device reprogramming including reason for changes	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.	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.	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).	Lifetime of the device (up to 15 years)

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): July 1, 2040
• Study Completion (Estimated): July 1, 2040

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: August 27, 2025
• First Posted (Estimated): September 5, 2025

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Extravascular implantable cardioverter-defibrillator; EV-ICD
• Other Study ID Numbers: BELIEVE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No