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
Subject or legally authorized representative provides written authorization and/or consent per institution and geographical
requirements
Subject is implanted with the Model 4396 LV lead connected and used for a pacing or sensing.
Subject within 30 days of implant
Exclusion Criteria
Subject who is, or will be inaccessible for follow-up at a site
Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)
Complete implant and follow-up data, including any product-related events at implant through the time of enrollment are unavailable
Sample Size
This study will consist of 1,016 patients implanted with Model 4396 lead enrolled from approximately
150 centers globally. The minimum Model 4396 enrollment of 1,016 leads results in approximately 600 leads followed for 5-years.
Data Collection
The primary objective of the PAS is to demonstrate that the Model 4396 lead-related complication-free
rate is greater than 92.5% at five years post-implant.
Followup Visits and Length of Followup
Subjects in the PAS will be followed for a minimum of 5 years from their
implant date.
Study follow-up visit schedules are based on a rolling visit window with the visit frequency: The required visit window is 210 days in length or approximately every 6 months from implant.
