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.
Objective: To study the long term (5 year) device safety and effectiveness in continued follow-up
of cohort B and six nested registries.
Design: A continued follow-up of Cohort B and six nested registries in IDE pivotal study, a prospective randomized, multi-center trial with two population cohorts undergoing transcatheter heart valve replacement therapy with SAPIEN XT THV.
Subjects will be all pivotal and CAP Patients enrolled in Cohort B and six nested registries (NR1, NR4, NR5, NR6) and who are not suitable for aortic valve surgery (i.e. inoperable patients).
Study Population Description
all pivotal and CAP Patients enrolled in Cohort B and four nested registries (NR1, NR4, NR5, NR6)
Currently, a total of 1790 patients from pivotal trials (560 from Cohort B and 1230
from the six registries) and 775 continued access (CAP) patients from the six nested registries (as of June 2, 2014) are available for continued follow-up.
Followup Visits and Length of Followup
Subjects will be followed annually through 5 years. Patients have been consented for up to
5 years follow-up, thus no re-consent is needed.
OSB Lead-Cont F/U of the IDE inop pts cohort(B)