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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


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
Out of 603 subjects enrolled, 575 underwent an implanted attempt, with 557 of them successfully implanted. Of those 557 pateints, 213 patients have had a lead repositioning, 83 were due to atrial oversensing, 77 were due to suboptimal R-wave sensing, 44 implant attempts had both atrial oversensing and suboptimal R-wave sensing, and 4 had an unknown relation. Additionally, 88 implant attempts required re-tunneling and of those, 17 were due to atrial oversensing, 41 due to suboptimal R-wave sensing, 27 related to both, and one was unknown relation.
112 adverse events were reported in 94 patients. 103 were fully adjudicated by the CEC. Among the adjudicated events, 96 were deemed to be related to the EV-ICD system and/or EV-ICD procedure. Of the 103 fully adjudicated events for the 603 patients enrolled, 27 classified as major complication, 34 are serious, 71 are system related and 58 are procedure related. None were unanticipated.
There were a total of 39 inappropriate shocks in 26 patients.

Effectiveness Results
The sponsor summarized the electrical performance. The most common pacing vector testing was Ring 1 to Coil 2 with a mean of 5.5V. Pacing capture threshold at implant was consistent as enrollment increased. PCT was not measured at 6 or 12 months. Sensing at 12 month was similar to pivotal study. The average impedance remains consistent.
Among the 575 patients with implant attempts, 515 had defibrillation testing with 505 patients having a reported minimum energy where defibrillation was successful.
There are no significant concerns.
Actual Number of Patients Enrolled 603
Actual Number of Sites Enrolled 133
Patient Follow-up Rate At the time of the visit cutoff date, 145 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 10/17/2024 On Time
18 month report 04/19/2025 04/16/2025 On Time
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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