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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P220012 / PAS001 |
| Date Original Protocol Accepted |
10/20/2023
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| Date Current Protocol Accepted |
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| Study Name |
Enlighten PAS
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| Device Name |
Aurora EV-ICD System
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| General Study Protocol Parameters |
| Study Design |
Active Surveillance
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| Data Source |
Sponsor Registry
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The Enlighten PAS is a post-market approval registry and will be conducted within the Medtronic Product Surveillance Registry (PSR) platform. Patients intended to be implanted with an Aurora EV-ICD System are eligible for enrollment and must be consented prior to implant. Patients will be followed according to the expected routine care in the local geography. Registry data will be collected from newly patients both US and OUS. The primary objective of the PAS will be to demonstrate 5-year Aurora EV-ICD system or procedure related complication-free survival. Minimum enrollment will be 500 patients.
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| Study Population |
New adult patients intended to be implanted with the Aurora EV-ICD System both US and OUS.
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| Sample Size |
The minimum number of patients to be enrolled will be 500.
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| Key Study Endpoints |
The primary objective of the PAS will be the following:
1. To demonstrate 5-year Aurora EV-ICD system or procedure related complication-free survival > 79%
a. The following complications will be included in the analysis:
i. Death
ii. Permanent loss of defibrillation function due to mechanical or electrical dysfunction of the device
iii. Hospitalization
iv. Prolongation of an existing hospitalization by at least 48 hours
v. System revision (reposition, replacement, explant)
Ancillary objectives will include the following:
1. To estimate the Aurora EV-ICD System and/or procedure related complication=free survival probability as a function of time post-implant
2. Characterize the rate of abnormal battery depletion complications as a function of time post-implant
3. Summarize all device system revisions (e.g., reposition, replacement, explant) including reasons for modification and action taken
4. Summarize patient deaths
5. Summarize patient demographics and baseline medical history
6. Characterize extracardiac pacing sensation
7. Summarize ATP with spontaneous arrhythmias
8. Characterize asystole pacing
9. Characterize sensing and detection
10. Characterize defibrillation shock effectiveness for terminating spontaneous VT/VF arrhythmia
11. Characterize lead location and lead motion at implant
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| Follow-up Visits and Length of Follow-up |
The total estimated follow-up duration is through lifetime of device or ~10 years.
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