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		 P140031 S010/ PAS001
Date Original Protocol Accepted 07/23/2018
Date Current Protocol Accepted 07/23/2018
Study Name Continued f/u of premarket cohort
Device Name SAPIEN 3 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 PIIS3i 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
1 year report 06/16/2017 06/13/2017 On Time
2 year report 06/16/2018 06/14/2018 On Time
3 year report 06/16/2019 06/17/2019 Overdue/Received
4 year report 06/16/2020 06/18/2020 Overdue/Received
5 year report 06/16/2021 06/17/2021 Overdue/Received
6 year report 06/16/2022 06/16/2022 On Time
7 year report 06/16/2023 06/14/2023 On Time
8 year report 06/16/2024    
final report 02/28/2025    


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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