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.
This is a two-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 TAH-t.
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 as of June 30, 2013, and entered into the INTERMACS Registry.
It is assumed that the 3-month survival of patients implanted with the CSS Console is 86% (regarded as a fixed amount), and that the 3-month survival of patients implanted with the Companion 2 Driver System is 86%. This will provide 93% power to demonstrate non- inferiority, defined as a difference of 10%.
The primary endpoint parallels the study hypothesis: Transplant prior to three months, transfer to
the Companion 2 Driver System prior to three months, continuing implant driver support prior to
3 months, or death prior to any of the endpoints listed.
Adverse events and device-related adverse events
Followup Visits and Length of Followup
Subjects are obtained from the INTERMACS registry.
Patients will be followed at one week, one month,
three months, six months, and every six months thereafter. Patients will be followed until they reach one of the following endpoints:
Transplant prior to 3 months
Transfer to Freedom Driver support prior to 3 months