f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Enlighten PAS


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General
Study Status Study Pending
Application Number /
Requirement Number
P220012 / PAS001
Date Original Protocol Accepted 10/20/2023
Date Current Protocol Accepted  
Study Name Enlighten PAS
Device Name Aurora EV-ICD System
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
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.
Study Population New adult patients intended to be implanted with the Aurora EV-ICD System both US and OUS.
Sample Size The minimum number of patients to be enrolled will be 500.
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
Follow-up Visits and Length of Follow-up The total estimated follow-up duration is through lifetime of device or ~10 years.


Enlighten PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/19/2024    
1 year report 10/19/2024    
18 month report 04/19/2025    
2 year report 10/19/2025    
3 year report 10/19/2026    
4 year report 10/19/2027    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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