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 objective is to
evaluate the proportion of subjects experiencing a major (serious) adverse event within 12 months of the procedure.
The effectiveness objective is to evaluate the proportion of subjects whom experience technical success, closure success, and acute procedure success.
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. Eligible patients can be enrolled retrospectively.
The comparison group is the Historical Control.
One hundred (100) subjects will be enrolled at up to 50 U.S. sites and additional
sites in Europe and Canada.
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 are followed for five years.
Primary safety endpoint:
Any major (serious) adverse event within 12 months of the procedure. A serious
adverse event is defined as any untoward medical occurrence that:
results in death;
is a life-threatening adverse event;
requires inpatient hospitalization or prolongation of existing hospitalization;
results in persistent or significant disability/incapacity; or