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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P100029
Current Protocol Accepted 04/20/2011
Study Name Trifecta Valve PAS
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a multi-center, prospective, non-randomized,

post-approval study conducted in the United States

  show the rest ...
Study Population Description Subjects previously implanted with a Trifecta prosthetic valve at the selected sites during the IDE   show the rest ...
Sample Size The study will enroll approximately 300 subjects enrolled from approximately 6 U.S. sites that enrolled   show the rest ...
Data Collection Primary Endpoints: Late endocarditis and embolism (linearized) rates as compared to the FDA Draft Replacement   show the rest ...
Followup Visits and Length of Followup Five-years post implant

Final Study Results
Actual Number of Patients Enrolled 245
Actual Number of Sites Enrolled 6
Patient Followup Rate 94.7%
Final Safety Findings No Unanticipated Adverse Device Effects (UADE¿s) was reported during the continued follow-up study period. The   show the rest ...
Final Effectiveness Findings At 5-year visit, over 90% patients maintained at NYHA I level, and valve insufficiency was   show the rest ...
Study Strengths and Weaknesses Strength: long-term follow-up (5 years) with over 94.7% of follow-up rate

Weakness: The study population consisted   show the rest ...
Recommendations for Labeling Changes Because neither safety nor effectiveness data presented in the final report substantially alter the labeling   show the rest ...

Trifecta Valve PAS Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 10/19/2011 10/18/2011 On Time
one year report 04/19/2012 04/18/2012 On Time
18 month report 10/18/2012 10/16/2012 On Time
two year report 04/19/2013 04/16/2013 On Time
three year report 04/19/2014 04/16/2014 On Time
final report 10/31/2014 10/28/2014 On Time

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