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 is a single arm prospective multi-site study, to be conducted at up to 25
sites, inside and outside of the United States. This is a prospective, single-arm, multi-center study to be conducted in
the US, and outside the US. This study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years
Study Population Description
Study Population: Patients 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.
Sample Size
225 patiens at up to 20 sites
Data Collection
Primary safety endpoints include thromboembolism, hemorrhage, perivascular leak, and endocarditis. Secondary safety endpoints include blood
count data, death, explant, reoperation, non-structural valve dysfunction, structural valve deterioration, and hemodynamic data obtained through echocardiography.
Followup Visits and Length of Followup
Follow-up visits will occur postoperatively, at discharge, at 6 months, one year, and annually thereafter,
