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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Pamira EP PASSION PAS


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General
Study Status Ongoing
Application Number /
Requirement Number		 P980023 S113/ PAS001
Date Original Protocol Accepted 01/20/2023
Date Current Protocol Accepted  
Study Name Pamira EP PASSION PAS
Device Name Pamira ICD Leads
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives
Real World Evidence (RWE) methodology study with the purpose of evaluating safety data of BIOTRONIK’s Pamira lead using active monitoring of Medicare fee-for-service claims data. The study is a prospective, single-arm, non-randomized, observational cohort study using RWE methodologies from the Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION) project.
Study Population All U.S. patients registered in BIOTRONIK’s device tracking database and successfully implanted with a Pamira lead after U.S. market approval, who match a unique beneficiary ID in the Medicare claims dataset, have fee-for-service Medicare coverage during month of Pamira lead implant, and have at least 1 Medicare claim in the inpatient, outpatient, or carrier files.
Sample Size At least 750 patients.
Key Study Endpoints Primary endpoint: overall incidence of complications attributable to the Pamira lead through 5 years post-implant.
Secondary endpoints:
1) incidence of complications attributable to the Pamira or possibly attributable to the Pamira lead through 5 years post-implant, and 2) incidence of complications potentially related to the Pamira lead (e.g. cardiac perforation) not included in another primary or secondary endpoint.
Follow-up Visits and Length of Follow-up 5 years


Pamira EP PASSION PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 01/20/2024 01/18/2024 On Time
2 year report 01/20/2025    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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