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...


           

Prospective VSD Registry


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Other
Application Number /
Requirement Number		 P000049 / PAS001
Date Original Protocol Accepted 04/19/2002
Date Current Protocol Accepted 04/19/2002
Study Name Prospective VSD Registry
Device Name CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
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, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study is a prospective registry to evaluate the ongoing occurrence of major complications related to device or procedure, shunt closure status and fracture detection.
Study Population The CardioSEAL Septal Occlusion System with QwikLoad is indicated for use in adult and pediatric patients with complex ventricular septal defects, which are of significant size that they warrant closure and are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition. The study population is consistent with the indications for use. It includes patients of all ages with complex ventricular septal defects, who are at high risk for surgical closure due to a high risk anatomical condition or high risk medical condition.
Sample Size 55 patients, 18 sites
Key Study Endpoints Data collected will include baseline, procedural, and annual follow-up data. This includes demographics, diagnosis, prior procedures, devices used, defect size, and procedural success. The collection of the occurrence of major complications, such as embolization, device explant, or death will be collected annually. Recommended annual evaluations include a history and physical exam, an echocardiogram, and a chest x-ray. A fluoroscopy is recommended if the x-ray is "uncertain".
Follow-up Visits and Length of Follow-up Annual follow-up will be solicited for a period of 5 years after implantation.


Prospective VSD Registry Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
PAS Annual/PAS report 03/21/2008 03/21/2008 On Time
7 year report 03/31/2009 04/09/2009 Overdue/Received
Semi Annual Report 12/05/2009 11/18/2009 On Time
8 year report 03/31/2010 05/25/2010 Overdue/Received
semi annual report 10/31/2010 10/19/2010 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

-
-