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, comparative, randomized study of REPEL-CV in pediatric patients (<21 years of
age) undergoing cardiac procedures via sternotomy. The patient will be randomized to either treatment with REPEL-CV or no adhesion barrier.
Study Population Description
The population will be pediatric (<21 years of age) patients who are greater than 48
hours of age, requiring a first cardiovascular sternotomy procedure, on cardiopulmonary bypass and without delayed chest closure.
Sample Size
640 patients randomized and treated with either REPEL-CV (320 patients) or the untreated study-directed control
(320 patients), 15 sites
Data Collection
The primary safety endpoint will be the incidence of a composite measure based on the
patient-level incidence of the following two specific adverse events: 1) Re-operation for re-bleeding and/or cardiac tamponade; 2) Mediastinitis: defined as a deep sternal infection. The secondary safety endpoints will be: 1) The individual incidence of re-operation for re-bleeding and/or tamponade, and mediastinitis; 2) The specific incidence of mediastinitis, delayed constrictive pericarditis, sternal non-union, sternal dehiscence, and reoperation for bleeding and/or tamponade.
Followup Visits and Length of Followup
Patients will be followed for 6 months post initial sternotomy. However, patients who undergo a
planned (staged) second sternotomy (not to include: emergent re-entry, or mediastinitis, or re-operation for re-bleeding and/or tamponade) within 6 months of the first sternotomy will be followed for 3 months post the planned second sternotomy.
