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 multi-center, non-randomized trial, registry study designed to follow at least 101 patients
for 6 years (obtaining at least 606 patient years). The study will evaluate if there an increased incidence and risk of aortic regurgitation in a patient population 70 years of age or younger implanted with the ATS Medical, Inc., ATS 3f Aortic bioprosthesis, Model 1000 (Equine Pericardial bioprosthesis) undergoing isolated aortic valve replacement of his / her native aortic valve, or replacement of a failed prosthesis.
Study Population Description
For patients undergoing isolated aortic valve replacement of his / her native aortic valve, or
replacement of a failed prosthesis who are 70 years of age or younger at implant.
Sample Size
101 patients 70 years of age or less across 8 sites
Data Collection
Hemodynamic performance, specifically the proportion of regurgitation, will be used to evaluate the safety of
the valve. Hemodynamic performance will be evaluated with doppler echocardiographic studies at 3-6 months, 11-14 months and annually up to the 6 year postoperative evaluation. Values of mean gradient, peak gradient, EOA, EOA index (EOA/body surface area), performance index (EOA/pre-implant internal orifice area), CO, CO index, and valvular regurgitation will be presented.
Followup Visits and Length of Followup
Patients will be enrolled and followed preoperative, operative, at discharge (or postoperatively at less than
30 days, whichever comes last), 3-6 months, 11-14 months and annually (plus/minus 2 months) thereafter until they reach the six years follow-up visit. Doppler echocardiography is required at 3-6 months, 11-14 months and annually up to the 6 year postoperative evaluation.
