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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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SJM Brady MRI PAS


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General
Study Status Progress Adequate
Application Number P140033 / PAS001
Date Current Protocol Accepted 05/22/2020
Study Name SJM Brady MRI PAS
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source Admin Database
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Primary Objective: To determine the Tendril MRI RA and Tendril MRI RV lead-related complication-free rates at 5 years.

Secondary Objective: To determine the rate of cardiac tamponade or cardiac perforation events through 5 years.

The real-world approach to identify lead-related complications will use Abbott-maintained internal databases combined with CMS-maintained Medicare claims data. Every Abbott device has a unique combination of model and serial number that is preserved across Abbott databases and can be used to link data from these databases together.
Study Population Description All patients who has an implant of an SJM system along with a Tendril MRI RA and/or RV lead, meet inclusion/exclusion criteria, and link to Medicare FFS claims will be included in the analysis of the endpoints.
Sample Size Assuming the time to first complication follows an exponential distribution and the complication free survival at 5 years is 95%, a minimal sample size of 645 Tendril MRI RA and 645 Tendril MRI RV leads provides 80% power to reject the null hypotheses of 92.5% complication-free survival years at the 5% significance level. It is estimated that 23,230 Tendril MRI RA and 22,839 Tendril MRI RV lead implants will meet inclusion /exclusion criteria for this study, which greatly exceeds the minimal required sample size.
Data Collection Primary Endpoint: Freedom from Tendril MRI RA and/or RV lead-related complications through 5-years of follow-up.

Secondary Endpoint: The secondary outcome measure is the rate of cardiac tamponade or cardiac perforation events. The objective is to characterize the rate of these events. All cardiac tamponade and cardiac perforations will be evaluated for their relationship to the Tendril MRI RA or Tendril MRI RV leads, reported and summarized.
Follow-up Visits and Length of Follow-up The study completion is 5 years after the final implant, June 30, 2018. The data retention period will be for 2 years after the submission of the final report.


SJM Brady MRI PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/01/2017 08/01/2017 On Time
one year report 01/31/2018 01/31/2018 On Time
18 month report 08/01/2018 08/01/2018 On Time
two year report 01/31/2019 01/29/2019 On Time
three year report 01/31/2020 01/31/2020 On Time
four year report 01/30/2021    
five year report 01/30/2022    


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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