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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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Enhanced Surveillance

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Study Status Revised/Replaced Study
Application Number P030011 S011/ PAS001
Date Current Protocol Accepted 08/20/2012
Study Name Enhanced Surveillance
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source External Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 2-armed (partially retrospective and partially prospective), multi-
center, non-randomized, cohort registry study that uses the INTERMACS Registry to compare performance of the TAH-t when supported with the Companion 2 Driver System vs. performance of the TAH-t when supported with the CSS Console.
Study Population Description Patients in the INTERMACS Registry who are implanted with the
Sample Size The study will be composed of 151 patients supported by the
Companion 2 Driver System and the last 151 patients supported by the CSS Console
Data Collection Primary Endpoint
The primary endpoint parallels the study hypothesis: Transplant prior to three months, transfer to the Freedom Driver System prior to three months, continuing implant driver support prior to 3 months, or death prior to any of the endpoints listed.

Secondary Endpoints
Adverse events and device-related adverse events
Follow-up Visits and Length of Follow-up 3 months, or when one of the primary endpoints is reached ¿ whichever occurs first.
Patients will be followed at one week, one month, and three months.

Enhanced Surveillance Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 11/14/2012 02/20/2013 Overdue/Received
one year report 05/16/2013 05/15/2013 On Time
18 month report-FINAL REPORT 12/16/2013 12/16/2013 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

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