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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Continued Access/Registry/IDE


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General
Study Status Completed
Application Number /
Requirement Number		 P920014 S016/ PAS001
Date Original Protocol Accepted 11/06/2002
Date Current Protocol Accepted 11/06/2002
Study Name Continued Access/Registry/IDE
Device Name THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This was a one-armed, observational, multi-site, prospective cohort study of patients implated with the Heartmate VE VAD.
Study Population The inclusion criteria were patients who were implanted with HeartMate VE left ventricular assist system for destination therapy, who were New York Heart Association Class IV heart patients, had been on optimal medical therapy for 60 out of the past 90 days, had a life expectancy of at least two years, and who were ineligible for cardiac transplanatation.
Sample Size 232 patients, 47 sites.
Key Study Endpoints Vital status, whether explanted or transplanted with an artificial heart, adverse events, neurocognitive function, quality of life, 6-minute walk test.
Follow-up Visits and Length of Follow-up Length of follow-up was one year. Follow-up visits were conducted at baseline, 1 month, 3 months, 6 months and 12 months
Interim or Final Data Summary
Interim Results Study completed, see final results.
Actual Number of Patients Enrolled 109 patients
Actual Number of Sites Enrolled 47 sites
Patient Follow-up Rate 99%
Final Safety Findings The success criteria for this study were met
Study Strengths & Weaknesses Weakness: There were some secondary endpoints for which data were missing on a large percent of subjects.
Recommendations for Labeling Changes None


Continued Access/Registry/IDE Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Final Report 05/22/2007 05/22/2007 On Time
Destination Therapy Registry Report 06/07/2007 06/07/2007 On Time
Extension Request to submit next report 12/26/2007 12/26/2007 On Time
Annual PAS Report 04/30/2008 05/12/2008 Overdue/Received
Final PAS Report 06/30/2008 09/10/2008 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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