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.
The study is a controlled, prospective, single-arm, multi-center trial.
Study Population Description
Patients who have successful Nit-Occlud PDA device implantation
The primary safety endpoint is the rate of serious adverse events reported in patients whom
device placement is attempted from the procedure through 5 years post-procedure. The primary effectiveness endpoint is the rate of complete closure of the ductus arteriosus as assessed by absence of residual flow at 5 years follow up by transthoracic echocardiography.
The secondary safety endpoint to demonstrate that the rate of adverse events reported through 5 years post procedure is no worse than the OPC of 3±3%.
The secondary effectiveness endpoint is to demonstrate that the echocardiographic closure at 12 and 36 months are no worse than the OPC rate of 85%.
Followup Visits and Length of Followup
Clinical assessments at 2, 12, 24, 36, 48, and 60 months