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
A prospective, single-arm, multi-center study that will enroll a minimum of 250 patients implanted with the
Carpentier-Edwards PERIMOUNT 7000 TFX, 72000 TFX and 73000 TFX, Magna Ease, Model 3300TFX, in order to achieve 101/Aortic valve replacement subjects each followed for a minimum of 8 years. A new enrollment study.
Study Population Description
Study Population: Patients must be at least 18 years of age eligible for mitral valve replacement.
Indication: It is intended for patients who require replacement of their diseased, damaged or malfunctioning native or prosthetic aortic valve and whose prognosis without aortic valve replacement is unacceptably poor. No comparator group.
A minimum of 250/Subjects at up to 25/Sites in order to obtain a minimum of 8
years data on 101 subjects.
Endpoints include thrombo-embolism, perivascular leak, hemorrhage, endocarditis, and heart failure. Early AE (within 30 days of
implant) are summarized as the percent (events /subjects) of subjects experiencing an early event. Late post- operative AE (>30 days post-implant) are summarized in terms of linearized rates (events /patient years).
Followup Visits and Length of Followup
8 years - Patients will be followed at discharge, 6-months, one year, and annually thereafter