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.
This study is a prospective, non-randomized, multi-site clinical study. The primary safety and efficacy endpoints
of this study are intended to be evaluated against the corresponding endpoints of the High Risk Cohort of the Muscular Ventricular Septal Defect Study.
Study Population Description
This device is indicated for use in patients with a complex VSD of significant size
to warrant closure (large volume left to right shunt, pulmonary hypertension and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.
100 patients 40 sites
The primary effectiveness endpoint include technical success, closure success, and acute procedure success. Technical success
is met for implant attempt subjects in whom a device is successfully deployed in the ventricular septal defect. Acute procedure success is met for implant attempt subjects who meet shunt closure success at procedure.
Followup Visits and Length of Followup
This study will enroll a maximum of 100 subjects at a maximum of 40 sites
in the United States and additional sites in Europe and Canada. Each study subject receiving a device will be followed for 60 months post-procedure, unless the device is explanted. An average of three or more subjects per month will be enrolled in the study. If subject follow-up drops below 80%, additional subjects will be enrolled to ensure a final population of 80 subjects either meet a defined endpoint or will be followed for five years. It is anticipated that all subjects will be enrolled within 40 months of study initiation.