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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Long Term


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General
Study Status Ongoing
Application Number /
Requirement Number		 P860057 S029/ PAS001
Date Original Protocol Accepted 12/05/2008
Date Current Protocol Accepted 01/24/2014
Study Name Long Term
Device Name CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives A prospective, single-arm, multi-center study that will enroll a
minimum of 250 patients implanted with the Carpentier-Edwards PERIMOUNT 7000 TFX, 72000 TFX and 73000 TFX, Magna Ease, Model 3300TFX, in order to achieve 101/Aortic valve replacement subjects each followed for a minimum of 8 years.
A new enrollment study.
Study Population Study Population: Patients must be at least 18 years of age
eligible for mitral valve replacement. Indication: It is intended for patients who require replacement of their diseased, damaged or malfunctioning native or prosthetic aortic valve and whose prognosis without aortic valve replacement is unacceptably poor.
No comparator group.
Sample Size A minimum of 250/Subjects at up to 25/Sites in order to obtain a
minimum of 8 years data on 101 subjects.
Key Study Endpoints Endpoints include thrombo-embolism, perivascular leak,
hemorrhage, endocarditis, and heart failure. Early AE (within 30 days of implant) are summarized as the percent (events
/subjects) of subjects experiencing an early event. Late post- operative AE (>30 days post-implant) are summarized in terms of linearized rates (events /patient years).
Follow-up Visits and Length of Follow-up 8 years - Patients will be followed at discharge, 6-months, one year, and annually thereafter for a minimum of 8 years.


Long Term Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/02/2009 03/02/2009 On Time
1 year report 08/29/2009 08/27/2009 On Time
18 month report 02/27/2010 02/23/2010 On Time
2 year report 08/29/2010 08/19/2010 On Time
3 year report 08/29/2011 08/29/2011 On Time
4 year report 08/28/2012 08/13/2012 On Time
5 year report 08/28/2013 09/11/2013 Overdue/Received
Correction to Info on 4 Year Report 08/30/2013 08/28/2013 On Time
6 year report 08/28/2014 08/27/2014 On Time
7 year report 08/28/2015 08/26/2015 On Time
8 year report 08/27/2016 08/26/2016 On Time
9 year report 08/27/2017 08/28/2017 Overdue/Received
10 year report 08/27/2018 08/24/2018 On Time
11 year report 08/27/2019 08/26/2019 On Time
12 year report 08/27/2020 08/27/2020 On Time
13 year report 08/27/2021 08/24/2021 On Time
14 year report 08/27/2022 08/25/2022 On Time
15 year report 08/27/2023 08/24/2023 On Time
final report 05/31/2024    


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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