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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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Aveir DR Real-World Evidence Study


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General
Study Status Ongoing
Application Number /
Requirement Number
P150035 S013/ PAS001
Date Original Protocol Accepted 11/22/2024
Date Current Protocol Accepted  
Study Name Aveir DR Real-World Evidence Study
Device Name Aveir™ Leadless System (Dual-Chamber)
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source Other Data Source
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study utilizes a real-world evidence method merging multiple real-world datasets from Abbott and CMS to assess the safety of the Aveir DR
LP in a large patient population.
Study Population All de novo patients who had an implant of both Aveir DR devices, meet inclusion/exclusion criteria, link to Medicare FFS claims, and survive past
30 days will be included in the analysis of this endpoint.
Sample Size Number of subjects: 1,805 patients
Assumptions for sample size estimation: Assuming an underlying
complication-free rate of 85% at 5 years, 900 evaluable subjects will
provide at least 85% power to meet a performance goal of 81% and reject
the null hypothesis at a 2.5% one-sided significance level. The sample size
calculation is based on the normal approximation to the binomial
distribution.
Number of sites: N/A
Sites location: N/A
Key Study Endpoints Primary: The primary endpoints are:
¿ Key acute complications through 30 days post implant procedure
¿ Freedom from key chronic complications from 31 days through 5
years post implant procedure
Secondary:
The secondary endpoints are
¿ Complication rate of the Aveir DR LP for key individual acute and
chronic complications
¿ Care of subjects at the end of device service
Descriptive:
1. Rates of other procedure-related acute complications
2. Survival at 5 years
3. Device longevity
4. Device longevity by device (atrial, ventricular)
5. Acute complications by device (atrial, ventricular)
6. Chronic complications by device (atrial, ventricular)
Additional analyses:
1. Cohort demographics and comorbidities
2. Device-device interaction
3. Effect of implanter experience with DR leadless pacemakers
4. Acute and chronic complications in patients with an atrial LP only
5. Battery performance
6. i2i performance
7. Acute and chronic complications in all Aveir patients (de novo and non
de novo)
8. Complications from cross talk occurring in patients programmed to
AAI+VVI mode
Follow-up Visits and Length of Follow-up 5 years


Aveir DR Real-World Evidence Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/26/2025    
1 year report 09/25/2025    
18 month report 03/26/2026    
2 year report 09/25/2026    
3 year report 09/25/2027    
4 year report 09/24/2028    
5 year report 09/24/2029    


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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