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
Site enrollment milestones not met,
Subject enrollment milestones not met
General Study Protocol Parameters
Study Design
Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N)
No
Data Source
New Data Collection
Comparison Group
No Control
Analysis Type
Descriptive
Study Population
Adult: >21
Detailed Study Protocol Parameters
Study Design Description
Prospective cohort study
Study Population Description
All adult patients treated with a Medtronic CRT-D device, meeting the expanded indication with QRS
duration < 150ms, enrolled into Medtronic¿s Product Surveillance Registry.
Sample Size
216 investigation sites, 500 patients
Data Collection
¿To estimate the 3-year survival probability of freedom from centrally adjudicated heart failure hospitalization or
all-cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration < 150ms.
¿To estimate the 3-year survival probability of freedom from centrally adjudicated heart failure event or all cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration < 150ms.
Followup Visits and Length of Followup
3 years, with the potential to be extended out to 5-years
