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
The study population will consist of patients who: were successfully implanted with the ACUITY Spiral
Lead, meet the study criteria.
Sample Size
1,700 patients, 150 sites
Data Collection
Chronic LV lead-related complication-free rate over a five year follow- up period
Followup Visits and Length of Followup
Patients will be followed until they have completed five years of
follow-up from implant or until
death, withdrawal, or closure of the registry.
Patients will have an in-clinic follow-up visit one month (15 to 29
days) post implant and then subsequently be followed according to the center?s standard follow-up schedule, with complete in-clinic system interrogation recommended to be at least once every six months.
