Post-Approval Studies (PAS) Database

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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Continued F/u of the Premarket ADO II PAS

General
Study Status	Completed
Application Number / Requirement Number	P020024 S037/ PAS001
Date Original Protocol Accepted	08/18/2013
Date Current Protocol Accepted	11/08/2013
Study Name	Continued F/u of the Premarket ADO II PAS
Device Name	AMPLATZER DUCT OCCLUDER II
Clinical Trial Number(s)	NCT00713700
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Infant: 29 days < 2 yrs, Child: 2 yrs < 12 yrs, Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Objectives	To examine the long term safety and effectiveness of the ADO II through continued follow-up of the 178 subjects from the ADO II IDE study in whom device placement has occurred.
Study Population	Subjects implanted with an ADO II device. No comparison group.
Sample Size	A total of 178 subjects were enrolled in the ADO II IDE study and were implanted with the device.
Key Study Endpoints	The primary ADO II PAS safety objective is to evaluate the rate of device serious adverse events (SAE) reported from the procedure through 5 years post-procedure.
Follow-up Visits and Length of Follow-up	5 years post-procedure - annual visits
Interim or Final Data Summary
Actual Number of Patients Enrolled	178 subjects implanted with the AMPLATZER Duct Occluder II constituted the post-approval study population
Actual Number of Sites Enrolled	25 sites
Patient Follow-up Rate	84.3% (150/178)
Final Safety Findings	Freedom from device- and procedure-related serious adverse events through 5 years was 97.9% (95% CI: 94.4 – 99.2).
Final Effect Findings	A total of 150 patients had their 60-month visits and 5 did not complete their echocardiograms. The rate of complete closure of the ductus arteriosus at 60 months post-procedure was 100% (145/145).
Study Strengths & Weaknesses	The study had a low rate of attrition, thus minimizing selection bias. It also provided results on the long- term (5 years) safety and efficacy of the device. A weakness of this study is that it did not collect data on race and/or ethnicity.
Recommendations for Labeling Changes	A labeling change is recommended to add the long-term safety and efficacy results from the pre-market cohort.

Continued F/u of the Premarket ADO II PAS Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
one year report	08/18/2014	08/13/2014	On Time
two year report	08/18/2015	07/30/2015	On Time
Final Report	12/30/2016	02/17/2017	Overdue/Received

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background