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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-Berlin Heart Comprehensive Reg Based Surv


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General
Study Status Study Pending
Application Number P160035 / PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-Berlin Heart Comprehensive Reg Based Surv
General Study Protocol Parameters
Study Design Active Surveillance
Data Source External Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Design Description The primary objective of the surveillance plan is to evaluate the
occurrence of stroke (ischemic or hemorrhagic) while on EXCOR Pediatric support within the first 180 days post-implant and if differences exist based on anticoagulation strategy.
Study Population Description Children who are transplant eligible in need of mechanical

circulatory support and are supported with the EXCOR Pediatric will be included in this surveillance. No additional inclusion/exclusion criteria will apply. No comparative group will be included.

Sample Size A minimum of 62 subjects implanted with EXCOR Pediatric will allow comparison to a pre-specified performance goal for stroke while on device of 30%.

Data Collection The primary endpoint for this study will be the rate of stroke (ischemic or hemorrhagic) within the first 180 days post- implant. The primary endpoint will also be stratified by anticoagulation regimen.



Secondary safety endpoint: Adverse Events will be summarized as the rate per patient-month.



Secondary effectiveness endpoint: Device effectiveness will be summarized as the proportion of subjects experiencing a successful outcome.

Successful outcome is defined as survival to recovery/successful weaning, or survival to transplant, or survival on EXCOR® Pediatric at 180 days post-implant.

Follow-up Visits and Length of Follow-up Patients are to be followed for 180 days post implant or to outcome (whichever is earlier).



OSB Lead-Berlin Heart Comprehensive Reg Based Surv Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/05/2017 01/08/2018 Overdue/Received
one year report 06/06/2018 06/07/2018 Overdue/Received
18 month report 12/05/2018    
two year report 06/06/2019    
three year report 06/05/2020    
four year report 06/05/2021    
final report 05/05/2022    


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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