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
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
Detailed Study Protocol Parameters
Study Design Description
Prospective cohort study
Study Population Description
Any patient, who meets the inclusion criteria, does not meet the exclusion criterion and provides
informed consent will be enrolled in the registry.
Inclusion Criteria
¿X Patients eligible for implantation with an S-ICD System, OR patients previously implanted with an S-ICD System Clinical Investigation (IDE G090013)
¿X Willing and able to provide written informed consent or have informed consent a provided by a legal representative
Exclusion Criterion
¿X Remaining life expectancy of less than 360 days
Sample Size
1616 patients from approximately 50 investigational centers (up to 150) in the US
Data Collection
The primary safety endpoint of the study is the Type I Complication Free Rate at
60 months, which will be compared to a performance criterion
The primary effectiveness endpoint is the Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months, which will be compared to a performance criterion.
The secondary safety endpoint of the study is the Electrode-Related Complication Free Rate at 60 months, which will be compared to a performance criterion.
The secondary effectiveness endpoint is First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF through 60 months, which will be compared to a performance criterion.
Followup Visits and Length of Followup
Data will be collected through the 60th month (1800 days) post implant.
Data will be collected
from each patient at enrollment, implant, annual follow-up visits and from unscheduled follow up visits associated with system/procedure-related complications or spontaneous episodes.
