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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Continued f/u of premarket cohort


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General
Study Status Ongoing
Application Number /
Requirement Number		 P130009 S057/ PAS001
Date Original Protocol Accepted 11/04/2019
Date Current Protocol Accepted  
Study Name Continued f/u of premarket cohort
Device Name EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Continued follow-up of all living subjects who were enrolled in the PIIA cohort under the IDE (G090216). The objective of this PAS is to characterize the clinical outcomes annually through 10 years post-procedure.
Study Population All living subjects who were enrolled in the IDE
Sample Size All living subjects
Key Study Endpoints The key safety and effectiveness endpoints include all-cause mortality, all stroke, transient ischemic attack (TIA), myocardial infarction, new permanent pacemaker, new-onset atrial fibrillation, rehospitalization from symptoms of aortic stenosis and/or complications of the valve procedure, improvement per New York Heart Association (NYHA) Class, improvement per Kansas City Cardiomyopathy Questionnaire (KCCQ) and Euro Health Related Quality of Life (EQ-5D), valve performance and durability, and aortic valve re-intervention.
Follow-up Visits and Length of Follow-up 10 years


Continued f/u of premarket cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 09/12/2017 09/12/2017 On Time
two year report 09/12/2018 09/11/2018 On Time
three year report 09/12/2019 09/06/2019 On Time
four year report 09/12/2020 09/10/2020 On Time
5 year report 09/12/2021 09/09/2021 On Time
6 year report 09/12/2022 09/02/2022 On Time
7 year report 09/12/2023 09/12/2023 On Time
8 year report 09/12/2024    


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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