Enlighten Study: The EV-ICD Post Approval Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ventricular Arrhythmia, Tachycardia

Intervention / Treatment
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* Device: Defibrillation using EV-ICD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Patient is intended to receive or be treated with a EV-ICD device System and must be enrolled prior to the EV-ICD device implant procedure Exclusion Criteria: Patient who is, or is expected to be, inaccessible for follow-up Patient is excluded by local local law Patient is currently enrolled or plans to enroll in any concurrent drug and/or device study that may confound the PSR results
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Defibrillation using EV-ICD|Device: Defibrillation using the Extravascular ICD (EV-ICD)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication-free survival rate | To demonstrate 5-year Aurora EV-ICD system-related complication-free survival > 79% | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) |