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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 P060040 S005
Current Protocol Accepted 05/07/2010
Study Name Heartmate II Bleeding Study
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a prospective non-randomized observational study,with a primary objective of comparing high molecular   show the rest ...
Study Population Description Study Population: Patients who are identified pre-implant in the INTERMACS database as "Bridge to Transplant   show the rest ...
Sample Size 10 nonpulsatile and 5 pulsatile (HeartMate XVE, Thoratec PVAD) for a total sample size of   show the rest ...
Data Collection Primary endpoint is to examine the change high molecular weight mutlimer von Willebrand factor from   show the rest ...
Followup Visits and Length of Followup All subjects will be assessed pre-procedure and 7days, 30 days and 6 months after device   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 53 enrolled (36 included in analyses)
Actual Number of Sites Enrolled 2
Patient Followup Rate 18/52
Final Safety Findings All non-pulsatile VAD patients demonstrated significant reductions in vWF HMW multimer levels following VAD placement.   show the rest ...
Study Strengths and Weaknesses Weaknesses: First, there were too few patients in the pulsatile group to power the study.   show the rest ...
Recommendations for Labeling Changes None

Heartmate II Bleeding Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 07/21/2010 07/13/2010 On Time
final report 01/20/2011 01/20/2011 On Time

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