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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.

Links

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General
Application Number P060040 S005
Current Protocol Accepted 05/07/2010
Study Name Destination Therapy-INTERMACS
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 Historical Control
Analysis Type Analytical
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 registry of patients receiving the HeartMate II LVAS for the   show the rest ...
Study Population Description Study Populaton: The post-approval study is a prospective registry of patients receiving the HeartMate II   show the rest ...
Sample Size 247 patients, over 105 sites, utilizing the INTERMACS Registry
Data Collection The primary objective of the HeartMate II Destination Therapy Post-Approval Study is to assess two-year   show the rest ...
Followup Visits and Length of Followup Post implant, patients will be assessed at 1 week, 1, 3, 6, 12, and 24 months.
Final Study Results
Actual Number of Patients Enrolled 247
Actual Number of Sites Enrolled 61
Patient Followup Rate 99.6%
Final Safety Findings Most frequent overall:

Bleeding (54%, 0.84 per patient year [ppy]) Infection (57%, 0.88 ppy)

Respiratory failure (27%,   show the rest ...
Final Effectiveness Findings Success rate including transplant/recovery pts HMI II ¿ 139 (56%) vs. IDE ¿ 58 (44%);   show the rest ...
Study Strengths and Weaknesses High follow-up rate, but concerns about possible unreported adverse events. Without a requirement for device   show the rest ...
Recommendations for Labeling Changes yes


Destination Therapy-INTERMACS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 07/21/2010 07/13/2010 On Time
New Report 6 months 10/11/2010 09/30/2010  
1 year report 01/20/2011 01/18/2011 On Time
18 month report 07/21/2011 07/11/2011 On Time
2 year report 01/20/2012 01/20/2012 Overdue
3 year report-FINAL REPORT 01/19/2013 01/23/2013 Overdue/Received

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