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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PERIMOUNT Plus Pericardial Bioprosthesis Model 6900P


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General
Study Status Completed
Application Number /
Requirement Number		 P860057 S019/ PAS001
Date Original Protocol Accepted 05/09/2003
Date Current Protocol Accepted  
Study Name PERIMOUNT Plus Pericardial Bioprosthesis Model 6900P
Device Name CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study includes consecutive enrollment of all patients receiving valves.
Study Population All patients who received valve replacement
Sample Size All eligible patients who received a mitral valve transplant between 1999 and 2002, a minimum of 150 patients
Key Study Endpoints NYHA classification pre/post implant (efficacy) and Thromboembolism,Valve thrombosis, Hemorrhage (all and major), Perivalvular leak (all and major), Endocarditis, hemolysis, Structural valve deterioration, Nonstructural dysfunction, Death, reoperation, explant (Safety)
Follow-up Visits and Length of Follow-up 6 months and annually to 8 years
Interim or Final Data Summary
Interim Results Study completed, see final results.
Actual Number of Patients Enrolled 209 patients
Actual Number of Sites Enrolled 4 sites
Patient Follow-up Rate 71.3% were followed and alive at 96 months
Final Safety Findings There was a noteable improvement in New York Heart Association classification and adverse event rate typical for the valve,
Study Strengths & Weaknesses Adequate follow-up, weaknesses is no hypothesis or sample size calculations
Recommendations for Labeling Changes None noted, patients were still being followed up until 2010


PERIMOUNT Plus Pericardial Bioprosthesis Model 6900P Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
4 year report 05/08/2007 08/22/2007 Overdue/Received
Final Report 12/14/2007 12/14/2007 On Time


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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