f Post-Approval Studies (PAS) Database
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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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Study Status Ongoing
Application Number /
Requirement Number
P150035 S003/ PAS001
Date Original Protocol Accepted 06/29/2023
Date Current Protocol Accepted  
Study Name Aveir DR Real-World Evidence Study
Device Name Aveir DR 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 dual-chamber Aveir Leadless Pacemaker device (aka DR 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 DR LP safety in a large patient population.

Study Population All de novo patients implanted with the Aveir DR LP who successfully link to Medicare FFS data will be included in the analysis, starting at market approval and continuing for approximately one year or longer, if necessary, to include a minimum of 1,805 subjects. Patients implanted with an Aveir atrial LP only (i.e., without a ventricular LP) will be analyzed in additional analysis and not in the primary and secondary analyses.
Sample Size 1805
Key Study Endpoints Primary Endpoints:
1. Acute complications through 30 days post implant procedure
2. Freedom from chronic complications from 31 days through 5 years post implant procedure

Secondary Endpoints:
1. Complication rate of the Aveir DR LP for key individual acute and chronic complications
2. Care of subjects at the end of device service

Descriptive Endpoints and Analyses:
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 include:
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)

Follow-up Visits and Length of Follow-up The study completion is 5 years after the final implant.
Interim or Final Data Summary
Actual Number of Patients Enrolled 345
Actual Number of Sites Enrolled 147
Final Safety Findings 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.
Final Effect Findings N/A

Aveir DR Real-World Evidence Study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 12/28/2023 12/15/2023 On Time
1 year report 06/28/2024    
18 month report 12/27/2024    
2 year report 06/28/2025    
3 year report 06/28/2026    

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