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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Continue Follow-Up of Premarket Cohort


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General
Study Status Completed
Application Number /
Requirement Number		 P100041 / PAS001
Date Original Protocol Accepted 11/02/2011
Date Current Protocol Accepted 01/31/2012
Study Name Continue Follow-Up of Premarket Cohort
Device Name EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
General Study Protocol Parameters
Study Design Randomized Clinical Trial
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 Cohort B device patients from premarket study. Premarket study was a prospective, controlled, multi-center pivotal trial.
Study Population Cohort B ¿ Non-surgical patients undergoing transcatheter
aortic valve implantation (treatment) via transfemoral delivery vs. best medical management (control)
Sample Size 350 patients in the best medical therapy cohort (Cohort B).
25 sites
Key Study Endpoints Cohort B: (1) Freedom from death, over the duration of the trial and (2) Composite of death and recurrent hospitalization
Follow-up Visits and Length of Follow-up Minimum of 5 years


Continue Follow-Up of Premarket Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/02/2012 08/01/2012 Overdue/Received
one year report 11/01/2012 11/01/2012 On Time
18 month report 01/31/2013 02/01/2013 Overdue/Received
two year report 07/31/2013 08/01/2013 Overdue/Received
three year report-final report 07/30/2014 07/30/2014 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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