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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Long term


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General
Study Status Completed
Application Number /
Requirement Number		 P020024 / PAS001
Date Original Protocol Accepted 05/14/2003
Date Current Protocol Accepted 05/14/2003
Study Name Long term
Device Name AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study was intended to evaluate long term safety and effectiveness issues that may not have been adequately addressed during the clinical investigation.
Study Population The AMPLATZER Duct Occluder is a percutaneous, transcatheter occlusion device and is indicated for the non-surgical closue of patent ductus arteriosus. The only requirement for enrollment into the Post-Approval Study was prior enrollment in the Phase II patent ductus arteriosus clinical investigation.
Sample Size 435 patients. 20 sites
Key Study Endpoints No endpoints were specified.
Follow-up Visits and Length of Follow-up A follow-up visit at either five, six, or seven years was considered to be a "final" follow-up visit. If a subject has already completed a five year visit, they would not return for a six or seven year visit. However, a subject who missed their five year follow-up could be re-consented and seen after the five year window ends for a final follow-up at six or seven years. Subjects unwilling or unable to return for an office visit had the option of a phone interview.
Interim or Final Data Summary
Actual Number of Patients Enrolled 435 patients
Actual Number of Sites Enrolled 20 sites
Patient Follow-up Rate 35%
Final Safety Findings All remaining patients had demonstrated complete closure of the ductus.
Study Strengths & Weaknesses Strengths: It is very difficult to conduct long term follow-up in this pediatric population. Therefore, any attempt to gather long term data on this group is to be applauded. Weaknesses: Very poor follow-up.
Recommendations for Labeling Changes There were no recommendations for changes to the labeling based on the results of the post-approval study.


Long term Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
4 year report/6 months data 05/14/2007 05/14/2007 On Time
12 month data report 11/13/2007 11/13/2007 On Time
5 year report 05/12/2008 05/13/2008 Overdue/Received
6 year report - Final Report 05/12/2009 11/14/2008 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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