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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This study is a multi-center, prospective, non-randomized,
post-approval study conducted in the United States
Study Population Description
Subjects previously implanted with a Trifecta prosthetic valve at the selected sites during the IDE
clinical investigational study and meet all eligibility criteria for this clinical study will be invited to participate.
Sample Size
The study will enroll approximately 300 subjects enrolled from approximately 6 U.S. sites that enrolled
subjects in the Trifecta¿ valve IDE study to result in a minimum of one-hundred-sixty (160) subjects followed for five (5) years from their Trifecta implant procedure.
Data Collection
Primary Endpoints: Late endocarditis and embolism (linearized) rates as compared to the FDA Draft Replacement
Secondary Endpoints: valve thrombosis, major bleed, all
paravalvular leak, major paravalvular leak, reoperation, explants,
non-structural dysfunction, structural deterioration, valve related
death, embolism, endocarditis, valve thrombosis, major bleed, all paravalvular leak, major paravalvular leak, reoperation, explants, nonstructural dysfunction, structural deterioration and valve-related death, New York Heart Association (NYHA) functional classification status at each interval, and hemodynamic performance at each interval.
