• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...


             

OSB Lead-CELESTIAL Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Application Number P070008 / PAS001
Current Plan Approved 12/23/2010
Study Name OSB Lead-CELESTIAL Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a 5-year, multi-center prospective cohort study designed to follow at least 2,000 patients implanted with BIOTRONIK's Corox OTW(-S) BP left ventricular lead.
Study Population Description The study includes patients who require treatment for advanced heart failure through any CRT-P or CRT-D. Patient must be successfully implanted with a BIOTRONIK CRT system, including a Corox OTW(-S) BP left ventricular lead, from 7-180 days prior to enrollment.
Sample Size This post- approval registry will include a minimum of 2,500 patients from up to 100 sites in the United States with. a minimum of 600 evaluable subjects for the Corox OTW-L BP lead which assumes an equal 1/3 distribution of each lead model (Corox OTW BP LV lead, Corox OTW-S BP LV lead, and Corox OTW-L BP LV lead). The estimated sample size requirement is based on both primary safety endpoints: a non-inferiority comparison (with รค of 5%) of the overall SAE free-rate to 92.5% at 5 years, and a non-powered, superiority comparison for those individual lead-related SAE to 1% at 5 years.
Data Collection Primary Endpoint 1 evaluates the overall incidence of serious adverse events related to the Corox over-the-wire BiPolar Left Ventricular leads. Primary Endpoint 2 evaluates the incidence of each type of serious adverse events that contributes to Primary Endpoint 1.
Follow-up Visits and Length of Follow-up Patients will be seen for routine follow-up visits per their institutional standard of care (typically every 3-4 months for a cardiac resynchronization therapy-defibrillator and every 6 months for a cardiac resynchronization therapy-pacer), but not to exceed every 6 months.
Final Study Results
Interim Safety Information Thirty patients (5.3%) experienced an adverse event; these were reviewed and adjudicated by the Clinical Events Committee. One primary endpoint adverse event was reported in 565 subjects over a cumulative implant duration of 4227.6 months (352.3 years). The adverse event occurred on day 87, and the current estimated freedom from adverse events is 99.8% for implant times 87 days or longer. There were 36 (8%) subjects with elevated thresholds at implant, and 56 (12%) subjects with elevated thresholds at any follow-up. This number includes all subjects with a threshold greater than 3 Volts or 3.5 Volts, at implant or follow-up respectively, regardless of measured pulse width.


OSB Lead-CELESTIAL Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 05/12/2009 05/08/2009 On Time
18 month report 11/10/2009 11/06/2009 On Time
2 year report 05/12/2010 05/07/2010 On Time
30 month report 11/10/2010 11/08/2010 On Time
3 year report 05/12/2011 05/10/2011 On Time
42 month report 11/10/2011 11/07/2011 On Time
4 year report 05/11/2012 05/08/2012 On Time
54 month report 11/09/2012 11/08/2012 On Time
5 year report 05/11/2013 05/07/2013 On Time
66 month report 11/09/2013 11/06/2013 On Time
6 year report 05/11/2014 05/08/2014 On Time
7 year report 05/11/2015 05/08/2015 On Time
8 year report 05/11/2016 05/06/2016 On Time
9 year report 05/11/2017    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

Related Links

-
-