Post-Approval Studies (PAS) Database

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

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	07/31/2024	08/01/2024	Overdue/Received

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background