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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Newly Enrolled Study


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General
Study Status Completed
Application Number /
Requirement Number		 P110021 / PAS002
Date Original Protocol Accepted 10/19/2012
Date Current Protocol Accepted 09/13/2013
Study Name Newly Enrolled Study
Device Name EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Retrospective/Prospective Cohort Study
Study Population High risk patients undergoing transcatheter heart valve replacement therapy
with severe symptomatic native aortic stenosis.
Sample Size A total of 5000 subjects combined for P110021 & P100041 patients enrolled into the STS/ACC TVT Registry in all US sites.
Key Study Endpoints Two primary endpoints: stroke at 30 days and 1 year
Follow-up Visits and Length of Follow-up 5 years
Discharge, 30 days and 1 year as well follow-up at 2 years, 3 years, 4 years
and 5 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 4994
Actual Number of Sites Enrolled 209
Patient Follow-up Rate year 1: >80%; year 2-5: <80%
Final Safety Findings All-cause mortality at 5 years: 64.2%
Stroke at 5 years: 13.9%
TIA at 5 years: 4.2%
Aortic Valve Re-intervention at 5 years: 3.1%
Re-intervention on Unspecified Valve at 5 years: 0.5%
New Requirement for Dialysis at 5 years: 4.8%
Final Effect Findings Survival at 5 years: 35.8%
Study Strengths & Weaknesses Strength: Large number of real-world patients enrolled in a relatively short period of time (about 10 months).
Weakness: Drop in follow-up rate post 1 year due to the inherent limitations in linking the TVT Registry with the CMS claims database.
Recommendations for Labeling Changes No. Device has been discontinued due to obsolescence.


Newly Enrolled Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/19/2013 04/25/2013 Overdue/Received
one year report 10/19/2013 10/15/2013 On Time
18 month report 04/19/2014 04/17/2014 On Time
two year report 10/19/2014 10/15/2014 On Time
three year report 10/19/2015 10/13/2015 On Time
four year report 10/18/2016 10/12/2016 On Time
five year report 10/18/2017 10/19/2017 Overdue/Received
Final Report 08/20/2018 08/22/2018 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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