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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 Ongoing
Application Number /
Requirement Number		 P220012 / PAS001
Date Original Protocol Accepted 10/20/2023
Date Current Protocol Accepted 04/24/2024
Study Name Enlighten PAS
Device Name Aurora EV-ICD System
Clinical Trial Number(s) NCT04060680 
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Interim or Final Data Summary
Interim Results Safety Results
All twenty-three (23) subjects had successful implants of the Aurora EV-ICD device system. Adverse events were reported in five of twenty-three (5/23) patients. Three (3) were serious, none were unanticipated. All 5 were procedurally related. There were no device deficiencies, study deviations, system modifications, subject exits, or subject deaths.
64% had a lead repositioning, Eight (8) due to atrial oversensing, and 4 due to suboptimal R wave sensing. Three (3) required re-tunneling. All re-tunneling occurred during initial implant.
Actual Number of Patients Enrolled 23
Actual Number of Sites Enrolled 12
Patient Follow-up Rate At the time of the visit cutoff date of 01-DEC-2023, no follow-up visits were reported.
Final Effect Findings N/A


Enlighten PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/19/2024 04/17/2024 On Time
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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