Observational BELgian Registry of Implanted EV-ICD to Evaluate Parameters and Complications of the New Device in Real World Settings
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAZ Sint-Jan AV
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years old
Previous or planned EV-ICD implantation (successful or not)
Informed consent signed
Disqualifiers
Patients who did not undergo any step of the implantation procedure
Trial population
All patients who underwent or will undergo an EV-ICD implantation in Belgium, whether successful or not, can be included in this registry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Number of delivered therapies (ATP and shocks)
Total number of therapies delivered by the device, including antitachycardia pacing and shocks (Unit: count)
Time frame
Lifetime of the device (up to 15 years)2
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).
Time frame
Lifetime of the device (up to 15 years)3
Proportion of delivered therapies that were successful
Percentage of therapies delivered by the device that successfully terminated the targeted ventricular arrhythmia.
Time frame
Lifetime of the device (up to 15 years)4
Tracking procedural and device-related complications
Tracking procedural and device-related complications during the lifetime of the device
Time frame
Lifetime of the device (up to 15 years)Secondary outcomes
1
Change in sensing amplitude over time
Change in device-recorded sensing amplitude (in mV) from implantation to follow-up visits.
Time frame
Lifetime of the device (up to 15 years)2
Change in pacing threshold over time
Change in pacing threshold (in Volt) measured during device follow-up from implantation to 15 years.
Time frame
Lifetime of the device (up to 15 years)3
Change in lead impedance over time
Change in lead impedance (in Ohm) from implantation to 15 years of follow-up.
Time frame
Lifetime of the device (up to 15 years)4
Change in battery longevity estimates over time
Change in estimated battery longevity (in years) as reported by the device at each follow-up visit.
Time frame
Lifetime of the device (up to 15 years)Sponsors and contacts
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Source ClinicalTrials.gov