Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

HeartAssist 5 Pediatric VAD


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Terminated
Application Number /
Requirement Number		 H030003 / PAS001
Date Original Protocol Accepted 02/25/2004
Date Current Protocol Accepted 10/01/2010
Study Name HeartAssist 5 Pediatric VAD
Device Name DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Objectives This study is a prospective non-randomized single-armed registry study of pediatric patients implanted with the DeBakey VAD Child device.
Study Population Pediatric patients (5-16 years old, with body surface areas >= 0.7m2 and <= 1.5m2). Indication: For patients who are in New York Heart Association Class IV end-stage heart failure, refractory to medical therapy and who are listed as candidates for cardiac transplant.
Sample Size 50 patients, the number of sites were not specified
Key Study Endpoints Data collected for the registry will be taken from measurements routinely assessed in children with life threatening congestive heart failure. Baseline parameters to be assessed will include demographics, medical history (e.g. ventilator, dialysis, ionotropic, or antiplatelet support, echocardiographic and catheterization assessments, etc). At the time of implant, pump parameters, adverse events, etc will be documented. During support (i.e. post DeBakey VAD Child implantation), data will be collected at week 1 and months 1, 3 and 6. Parameters that will be assessed include pump operation, quality of life (PedsQL), neurological exam, echocardiography, hemodynamics (on POD 3 and on day of catheter removal). Data will also be collected at the time of explant and death (pump parameters and cause of death).
Follow-up Visits and Length of Follow-up After device implantation, patient functional assessment (quality of life, neurological and cardiac) and device performance will be assessed 1, 3 and 6 months post implant and at anytime after a neurological event.


HeartAssist 5 Pediatric VAD Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
56 month report 10/19/2005 10/19/2009 On Time
Annual Report 03/12/2010 03/09/2010 On Time
annual report 05/16/2011 05/16/2011 On Time
report 05/25/2012 05/30/2012 Overdue/Received
yearly report 08/26/2013 10/16/2013 Overdue/Received
yearly report 08/26/2014 01/26/2015 Overdue/Received


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

-
-