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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 P100010
Most Recent Protocol Version Approved 08/23/2011
Study Name Sustained Treatment of Paroxysmal Atrial Fibrillat
Study Status Progress Inadequate
Study Progress Reason Subject enrollment milestones not met
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
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 is a prospective, one-armed, multi-center, non-randomized study.
Study Population Description Patients included in this study will have:

A diagnosis of paroxysmal atrial tachycardia, with at least   show the rest ...
Sample Size 370 enrolled with procedure attempts at 30 new user investigational sites and up to 15   show the rest ...
Data Collection Cryoablation procedure events and chronic treatment failure at 3 years, and major adverse atrial fibrillation   show the rest ...
Followup Visits and Length of Followup

The length of follow-up will be five years.

Follow-up visits will occur at discharge,   show the rest ...


Sustained Treatment of Paroxysmal Atrial Fibrillat Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 06/17/2011 08/19/2011 Overdue/Received
one year report 12/17/2011 12/08/2011 On Time
18 month report 06/16/2012 06/14/2012 On Time
two year report 12/16/2012 12/12/2012 On Time
three year report 12/16/2013 12/16/2013 On Time
four year report 12/16/2014    
five year report 12/16/2015    

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