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NCT06048731 Clinical Trial

Enlighten Study: The EV-ICD Post Approval Registry

Tachycardia Clinical Trial

Official title:
Enlighten Study: The EV-ICD Post Approval Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06048731
Other study ID # PSR: EV-ICD PAS/PMCF
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date October 31, 2037

Study information
Verified date June 2024
Source Medtronic
Contact EV-ICD PAS/PMCF Study manager
Phone 18006338766
Email rs.productsurveillanceregistry@medtronic.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm safety and effectiveness of EV-ICD in routine clinical practice, following commercial release of EV-ICD devices.

Description:

The Enlighten Study is a global, prospective, observational, multi-site registry study. This study is conducted within Medtronic's post-market surveillance platform. Eligibility for enrollment is based on market release dates for EV-ICD System within the geography in which the subject is enrolled. Patients enrolled in the Enlighten Study will be prospectively followed for the life time of device post-implant or until registry closure, patient death or patient exit from the registry (i.e., withdrawal of consent). Successfully implanted patients are expected to have scheduled follow-up visits approximately every 6 months, but at least annually, or as prompted by reportable adverse events. The total estimated registry duration is is through lifetime of device.

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Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Defibrillation using EV-ICD
Device: Defibrillation using the Extravascular ICD (EV-ICD)
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Sponsors (1)
Lead Sponsor Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Kuwait,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complication-free survival rate To demonstrate 5-year Aurora EV-ICD system-related complication-free survival > 79% 5 years
Secondary System and/or procedure related complication-free survival To estimate the Aurora EV-ICD System and/or procedure related complication-free survival probability as a function of time post-implant Procedure related complications assessed during and after the procedure/surgery; system related complications assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary Abnormal battery depletion complications Characterize the rate of abnormal battery depletion complications as a function of time post-implant Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary Summarize all device system revisions Summarize all device system revisions (e.g., reposition, replacement, explant) including reasons for modification and action taken Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary Patient deaths Summarize patient deaths Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary Patient demographics and baseline medical history Summarize patient demographics and baseline medical history Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary Characterize extracardiac pacing sensation Characterize extracardiac pacing sensation Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary Summarize ATP with spontaneous arrhythmias Summarize ATP with spontaneous arrhythmias Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary Characterize asystole pacing Characterize asystole pacing Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary Characterize sensing and detection Characterize sensing and detection Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary To characterize defibrillation shock effectiveness for terminating spontaneous VT/VF arrhythmia Characterize high voltage therapy effectiveness on device detected spontaneous ventricular episodes Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
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