Post-Approval Studies (PAS) Database

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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The Aveir VR RWE Study

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
Clinical Trial Number(s)	NCT01700244
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 91.8% (95% CI 90.2%-93.0%) as of the cut-off date for the 1512 enrolled subjects. Freedom from key chronic complications from 31 days to 10 years post implant was 100% at 1-month and 99.8% at the 14-month mark.
Actual Number of Patients Enrolled	1512
Actual Number of Sites Enrolled	334
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	05/29/2024	On Time
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

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background