In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
This is a two쳌]armed (partially retrospective and partially prospective), multi쳌]center, non쳌] randomized, cohort registry study
that uses the INTERMACS Registry to compare performance of the TAH쳌]t when supported with the Companion 2 Driver System vs. performance of the TAH쳌] t when supported with the CSS Console.
Study Population Description
Patients in the INTERMACS Registry who are implanted with the
TAH쳌]t and used the C2 Driver
System as their initial driver.
There will be 2 control groups used for comparison. One consists of
all Patients in the INTERMACS Registry who are implanted with the TAH쳌]t who used the CSS Console. The other consists only patients in the INTERMACS Registry who were implanted with the TAH쳌]t after The C2 Driver System began to be used (June 2012).
The study will be composed of 200 patients supported by the Companion 2 Driver System
and all INTERMACS Registry patients supported by the CSS Console at the time that the sample size for the C2 Driver System reaches 200.
The primary endpoint is survival rate, defined as noted above for the study hypotheses.
Followup Visits and Length of Followup
Per INTERMACS Registry (1 week, 1 month, 3 month, 6 month and every 6