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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Thoratec IVAD


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General
Study Status Completed
Application Number /
Requirement Number		 P870072 S027/ PAS001
Date Original Protocol Accepted 08/03/2004
Date Current Protocol Accepted 08/03/2004
Study Name Thoratec IVAD
Device Name THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a one armed, observational prospective cohort study of consectutive patients implanted with the Thoratec VAD.
Study Population Consecutive patients who meet the requirements for device use. This is for use in bridge to transplant patients who meet all of the following criteria: candidate for cardiac transplantation, imminent risk of dying before donor heart procurement, dependence on, or incomplete response to, continued vasopressor support. It is also indicated for postcardiotomy recovery
Sample Size 50 patients
Key Study Endpoints Number of patients weaned, transplanted, explanted, or died.
Follow-up Visits and Length of Follow-up Patients are followed until outcome is reached or for 180 days.
Interim or Final Data Summary
Interim Results Study completed, see final results.
Actual Number of Patients Enrolled 50 patients
Actual Number of Sites Enrolled 23 sites
Patient Follow-up Rate 100%
Final Safety Findings Of patients enrolled in the study, 52% died before weaned or transplanted
Study Strengths & Weaknesses The strength of the study was the 100% follow-up
Recommendations for Labeling Changes None


Thoratec IVAD Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Annual PAS Report 05/31/2007 05/31/2007 On Time
4 year report 08/02/2008 09/03/2008 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

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