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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-AMPLATZER PIVSD Occluder PAS


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General
Study Status Progress Adequate
Application Number H070005 / PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-AMPLATZER PIVSD Occluder PAS
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description To evaluate the safety and probable benefit of the AMPLATZER PIVSD Occluder in patients undergoing implantation of the PIVSD Occluder following an acute myocardial infarction. This is multicenter, retrospective non-randomized, observational study.

Study Population Description The intended population for the AMPLATZER™ PIVSD Occluder are patients with post-myocardial infarct muscular ventricular septal defect (VSD) who are not satisfactory surgical candidates. The study will enroll subjects in two cohorts:

First Cohort: All available Emergency and Compassionate PIVSD

Occluder subject data from 2011 to end of 2016.

All subjects belonging to this cohort must have undergone an attempt to close a post-infarct VSD using the AMPLATZER™ PIVSD Occluder.

Second Cohort: The second cohort will be comprised of subjects over the age of 18 who are successfully implanted with a PIVSD Occluder from 2011 onwards. The index procedure must have occurred >6 months prior to enrollment.

The subjects must meet following conditions:

Subject or subject’s legally authorized representative has

provided consent to participate in this study.

Subject’s post-procedure echocardiogram is evaluable and can be sent to the echocardiography core laboratory for residual shunt assessment.

Sample Size First Cohort: All available Emergency and Compassionate PIVSD Occluder subject data from 2011 to the end of 2016.

Second Cohort: A total of 30 subjects who have been successfully implanted with PIVSD occluder and have data for the residual shunt assessed by the echocardiography core laboratory post procedure will be enrolled from up to 50 centers in the US.

Data Collection Safety endpoints:

Acute Survival: is defined as survival for at least 24 hours following an attempted PIVSD device implant.

Chronic Survival: is defined as survival for at least 183 days post- procedure.



Effectiveness endpoints:

Technical Success: Technical success occurs when a subject is successfully implanted with a PIVSD device in the ventricular septal defect. An implant attempt occurs when the delivery system is inserted in the subject’s vasculature.

Acute Closure: is defined as the absence of a residual shunt greater than or equal to 3 mm, and will be assessed based on an echocardiogram obtained between 24 hours and 7 days post-procedure.

Chronic Closure: is defined as the absence of a residual shunt greater than or equal to 3 mm at 6 months.

Follow-up Visits and Length of Follow-up 6 months


OSB Lead-AMPLATZER PIVSD Occluder PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/11/2017 07/11/2017 On Time
one year report 01/10/2018    
18 month report 07/11/2018    
two year report 01/10/2019    
three year report 01/10/2020    
Final Report 07/10/2020    


Contact Us

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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