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 sub-study of the System Longevity Study. The Model 4196 Lead Chronic
Performance study is a nonrandomized, multi-site, world-wide study of implanted commercially available Model 4196 leads. Data will be collected prospectively; however, retrospective study enrollment will be allowed to include leads implanted through the Model 4196 IDE clinical trial. Subjects will be followed from their enrollment date, and at six month intervals through five years post-implant. The primary study question is to evaluate whether the SJ4 system complication-free rate is greater than 92.5% at 5 years
Study Population Description
The study will consist of patients rolled over from the pre-market study and patients newly
enrolled in the postapproval study all tracked within the System Longevity Study sponsor registry. These are patients indicated for chronicpacing and sensing in the left ventricle via thecardiac vein, when used in conjunction with a compatible Medtronic Cardiac Resynchronization Therapy system.
Sample Size
1778 patients, 60 sites
Data Collection
The endpoints include the complication free rate will be estimated based on the chronic (>
30 days post implant) clinical adverse events including 1) failure to capture, 2) failure to sense, 3) Undersensing, 4) Threshold rise, 5) Oversensing, 6) Abnormal pacing impedance, 7) Lead insulation breach, 8) Lead conductor fracture, 9) Extracardiac stimulation, 10) Cardiac perforation, 11) Lead dislodgement, and 12) Structural Lead Failure.
Followup Visits and Length of Followup
Patients will be followed every six months for 5 years
