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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PAS


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General
Study Status Completed
Application Number /
Requirement Number		 P860057 S016/ PAS001
Date Original Protocol Accepted 11/29/2001
Date Current Protocol Accepted  
Study Name PAS
Device Name CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
General Study Protocol Parameters
Study Design Prospective Cohort 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 is a prospective, observational, non-randomized, multi-center study of the Carpentier-Edwards pericardial bioprostesis.
Study Population Subjects were eligible for participation if they required mitral valve replacement, were average or better operative risk, and did not meet criteria for exclusion.
Sample Size 209 subjects, 7 sites
Key Study Endpoints Adverse event rate, New York Heart Association classificatioin, Hemodynamic performance
Follow-up Visits and Length of Follow-up Participants were followed at discharge, 6 months and 1 year and annually thereafter.for 7 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 7 sites
Patient Follow-up Rate 71%
Final Safety Findings Final report indicates acceptable device performance
Study Strengths & Weaknesses Strength: Prospective cohort study
Recommendations for Labeling Changes None


PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Final Report 02/29/2008 02/14/2008 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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