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 F/u of Premarket Cohort


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General
Study Status Completed
Application Number /
Requirement Number		 P110021 / PAS001
Date Original Protocol Accepted 10/19/2012
Date Current Protocol Accepted 10/19/2012
Study Name Continue F/u of Premarket Cohort
Device Name EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Interim or Final Data Summary
Actual Number of Patients Enrolled 115
Actual Number of Sites Enrolled 25
Patient Follow-up Rate 94.8%
Final Safety Findings At 5 year follow-up, the rates for major adverse events (in descending order) are all-cause mortality
65.8%, cardiovascular mortality 18.4%, reshospitalization 30.7%, bleeding (25.6%), major bleeding
21.0%, arterial vascular procedure 17.2%, major vascular complication 11.8%.
Final Effect Findings At 5 year follow-up, the mean values ± standard deviation for quality of life measures are:
KCCQ summary 69.1 ± 22.1, SF-12 Physical 34.9 ± 10.6, SF12 mental 52.2 ± 10.3, EQ-5D 0.7403 ± 0.2074.
Study Strengths & Weaknesses Strength: Longer-term (5-year) safety and effectiveness results are obtained and the device benefits over risks are sustained up to 5 years.

Weakness: smaller sample size, i.e. only 109 of the 115 eligible patients have completed the study follow-up. QoL follow-up rates at 3-5 years are low.
Recommendations for Labeling Changes Labeling update is not needed because Edwards Lifesciences LLC ceased US market distribution of the Edwards SAPIEN Transcatheter Heart Valve.


Continue F/u of Premarket Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/19/2013 04/19/2013 On Time
one year report 10/19/2013 10/16/2013 On Time
18 month report 05/09/2014 05/06/2014 On Time
two year report 10/19/2014 10/15/2014 On Time
final report 10/19/2015 04/03/2015 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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