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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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.

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OSB Lead-Chronic Performance Study


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General
Application Number P060039 / PAS002
Current Plan Approved 11/19/2013
Study Name OSB Lead-Chronic Performance Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
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 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,
Follow-up Visits and Length of Follow-up 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.
Final Study Results
Interim Safety Information The sponsor reports four adverse events (two complications, two observations not adjudicated by the cut-off date), six total study exits (including 2 deaths) and no deviations from the study plan. As of the data cut-off date, two deaths have been reported in this study. These deaths have not been reviewed by the Event Adjudication Committee and tabled as additional information was required from the center. Updated information regarding these deaths will be provided in the next report. There is limited information in this report upon which to make conclusions on the safety of this device.


OSB Lead-Chronic Performance Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 01/13/2009 06/04/2009 Overdue/Received
1 year report 02/02/2010 11/25/2009 On Time
18-month report 05/28/2010 05/28/2010 On Time
2 year report 11/26/2010 11/26/2010 On Time
30 month report 05/29/2011 05/27/2011 On Time
3 year report 11/26/2011 11/18/2011 On Time
42 month report 05/29/2012 05/23/2012 On Time
4 year report 11/29/2012 11/20/2012 On Time
54 month report 05/29/2013 05/23/2013 On Time
5 year report 11/29/2013 11/27/2013 On Time
66 month report 05/27/2014 05/27/2014 On Time
60 month report 05/29/2014 04/30/2014 On Time
6 year report 11/29/2014 11/21/2014 On Time
78 month report 05/29/2015 05/27/2015 On Time
7 year report 11/29/2015 11/23/2015 On Time
90 month report 05/29/2016 05/27/2016 On Time
8 year report 11/29/2016   Overdue
102 month report 05/29/2017    
Final Report 08/29/2017    


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

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