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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All Comers Registry


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General
Study Status Terminated
Application Number /
Requirement Number		 H100004 / PAS001
Date Original Protocol Accepted 12/16/2011
Date Current Protocol Accepted 07/27/2012
Study Name All Comers Registry
Device Name EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source Sponsor 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, Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Objectives The study will be an all-comers prospective registry
Study Population Patients implanted with the EXCOR Pediatric VAD per indications for use
Sample Size 49 patients (39 for complete follow-up), 10 to 50 sites
Key Study Endpoints Primary safety: serious adverse event rates of
Major Bleeding
Cardiac Arrhythmias
Pericardial Fluid Collection (with and without Tamponade)
Hemolysis
Hepatic Dysfunction
Hypertension
Major infection
Myocardial Infarction
Neurological Dysfunction
Psychiatric Episode
Renal Dysfunction
Respiratory Failure
Right Heart Failure
Arterial Non-CNS Thromboembolism
Venous Thromboembolism
Wound Dehiscence
Other

Primary effectiveness: transplant, recovery of left ventricular function or death
Follow-up Visits and Length of Follow-up 24 months post-implant
Pre-implant, Discharge, Post-implant at 3 & 6 weeks, 3, 6, 12, and 24 months


All Comers Registry Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/27/2013 02/11/2013 Overdue/Received
one year report 07/27/2013 07/31/2013 Overdue/Received
18 month report 02/26/2014 02/26/2014 On Time
two year report 07/27/2014 07/28/2014 Overdue/Received
interim report (3 year) 07/27/2015 04/30/2015 On Time
4 year report 07/27/2016 07/11/2016 On Time
final report 02/10/2017 02/09/2017 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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