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 with newly enrolled patients.
Study Population Description
Patients who have successful Nit-Occlud PDA device implantation
215 patients from up to 20 sites to achieve a sample size of 150 subjects
at 60 months post-procedure.
The primary safety endpoint is the serious device and/or procedure related
adverse event rate at 60
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 by transthoracic echocardiogram with 2-D color of color flow mapping and pulse wave Doppler (ECHO).
Followup Visits and Length of Followup
Clinical assessments at 2, 12, 24, 36, 48, and 60 months