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

NCT07156851 | Not Yet Recruiting

• 1 other identifier: BELIEVE
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Implantable Cardioverter Defibrillator (ICD)

Keywords

Extravascular implantable cardioverter-defibrillator; EV-ICD

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Change in sensing amplitude over time

  Lifetime of the device (up to 15 years)

• Change in pacing threshold over time

  Lifetime of the device (up to 15 years)

• Change in lead impedance over time

  Lifetime of the device (up to 15 years)

• Change in battery longevity estimates over time

  Lifetime of the device (up to 15 years)

• Accuracy of arrhythmia detection by the device

  Lifetime of the device (up to 15 years)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• At least 18 years old
• Previous or planned EV-ICD implantation (successful or not)
• Informed consent signed

You may not qualify if:

• Patients who did not undergo any step of the implantation procedure

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Central Study Contacts

Emma Christiaen

CONTACT

+32 50 45 32 93; SM-SJ-Cardiologie-Studies@azsintjan.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Principal Investigator

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: September 5, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): July 1, 2040
• Study Completion (Estimated): July 1, 2040
• Last Updated: September 5, 2025

Record last verified: 2025-08