f Post-Approval Studies (PAS) Database
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

The Aveir VR RWE Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Ongoing
Application Number /
Requirement Number		 P150035 / PAS001
Date Original Protocol Accepted 03/31/2022
Date Current Protocol Accepted  
Study Name The Aveir VR RWE Study
Device Name Aveir VR Leadless System
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The purpose of the post-approval study (PAS) is to evaluate the long-term safety of the single-chamber Aveir Leadless Pacemaker device (aka VR LP) using real-world evidence (RWE) methods. The study utilizes a real-world evidence method merging multiple real-world datasets from Abbott and CMS to assess the Aveir VR LP safety in a large patient population.
Study Population Adult (=22 years)
Sample Size 2100
Key Study Endpoints Primary Endpoints are:
- To assess freedom from key acute (30-day) complications post-implant procedure
- To assess freedom from key long-term (31 days through 10-year) complications post-implant procedure
Secondary Endpoints are:
- Complication rate of the Aveir VR LP for key individual acute and chronic complications
- Care of subjects at the end of device service
Descriptive Endpoints are:
- Rates of other procedure or device-related complications
- Survival at 10 years
- To assess device longevity
- Summarize study cohort demographics and comorbidities
- To assess device-device interaction
- To analyze effect of implanter experience with Aveir VR LP on safety performance
Follow-up Visits and Length of Follow-up 10 years
Interim or Final Data Summary
Interim Results Safety Results
Freedom from key acute complications through 30 days post implant was 91.2% (95% CI 87.6%-93.8%) as of the cut-off date for the 345 enrolled subjects. Enrolled subjects include patients with prior Cardiovascular Implantable Electronic Devices (CIED) as well as de novo patients (patients with no prior CIED implants).
Freedom from key chronic complications from 31 days to 10 years post implant was 99.7% event-free survival rate through a maximum follow-up time of 150 days.
Actual Number of Patients Enrolled 345
Actual Number of Sites Enrolled 147
Patient Follow-up Rate N/A


The Aveir VR RWE Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/29/2022 09/29/2022 On Time
progress report 05/31/2023 04/03/2023 On Time
1 year report 05/31/2023 05/30/2023 On Time
18 month report 11/30/2023 11/21/2023 On Time
2 year report 05/31/2024    
3 year report 05/31/2025    
4 year report 05/31/2026    
5 year report 05/31/2027    
6 year report 05/31/2028    
7 year report 05/31/2029    
8 year report 05/31/2030    
9 year report 05/31/2031    
10 year report 05/31/2032    


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

-
-