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
This study is a non-randomized, multi-site, clinical study of implanted commercially available Model 4195 leads.
Data will be collected prospectively; however, retrospective study enrollment will be allowed to include leads implanted through the Attain StarFix Model 4195 LV Lead pre-market study. All enrolled subjects have been implanted with a Model 4195 LV Lead. This study is designed to monitor long term performance of the Model 4195 lead and to identify individual failure modes.The objective of the study is to demonstrate that the Model 4195 lead-related complication-free probability is greater than 92.5% at five years post-implant.
Study Population Description
The Attain StarFix Model 4195 steroid eluting, transvenous lead with deployable lobe fixation is intended
for chronic pacing and sensing of the left ventricle via the cardiac vein, when used in conjunction with a compatible implantable pulse generator or implantable cardiac defibrillator.
Sample Size
1,016 patients will be enrolled to achieve an evaluable sample size of 600 for 5-year
follow-up for an interim analysis. 120 active centers enrolled in this study.
Data Collection
The primary objective of the study is to demonstrate that the Model 4195 lead-related complication-free
probability is greater than 92.5% at five years post-implant. Primary objective analysis will include all complications related to lead hardware or design failure. The complication free proportion will be estimated based on the chronic (> 30 days post implant) clinical adverse events including: 1) - Failure to capture, 2) Failure to sense / Undersensing, 3) Threshold rise, 4) Oversensing, 5) Abnormal pacing impedance, 6) Lead insulation breach, 7) Lead conductor fracture, 8) Extracardiac stimulation, 9) Cardiac perforation, 10) Lead dislodgement, and 11) Structural Lead Failure,
Followup Visits and Length of Followup
The follow-up schedule for this study is based on utilizing routine, scheduled office/clinic visits and
unscheduled office/clinic visits prompted by symptoms or complaints. Follow-up office/clinic visits post-enrollment are to occur at a minimum of every 6 months, no longer than 210 days apart.
