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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) of 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 Lead Performance


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General
Study Status Progress Adequate
Application Number P080006 / PAS002
Date Current Protocol Accepted 12/05/2013
Study Name OSB Lead-Chronic Lead Performance
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 utilizes the Medtronic¿s Post-Approval Network Product

Surveillance Registry (PSR) designed to conduct non-randomized, active prospective post-market Surveillance. The Registry is sponsored by Medtronic and is comprised of a global network of hospitals, clinics and clinicians from which reliable ¿real world¿ product safety and patient clinical outcome information is generated.

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.
Follow-up Visits and Length of Follow-up Patients will be followed every six months for 5 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 1847
Actual Number of Sites Enrolled 124
Patient Follow-up Rate 52.41%
Final Safety Findings The Chronic Performance Post-Approval Study met the primary endpoint demonstrating that the Medtronic Attain Ability 4196 lead-related complication-free rate is greater than 92.5% at five years implant with a 95.68% complicate-free rate at five years with a lower 2-sided confidence bound of 94.47% and an upper 2-sided confidence bound of 96.63%.
Final Effect Findings As of R073, there were a total of 82 threshold rises at implant and 133 threshold rises at follow-up. Of those, 72 threshold rises from 31 different leads were reported as lead related complications, including 22 were counted against the complication-free survival estimate (CFSE) based on the study protocol definition. There were 20 impedances out of range at implant and 9 impedances out of range at follow- up. One impedance out of range was reported as a lead related complication.
Study Strengths & Weaknesses The Chronic Performance PAS met the primary endpoint and provided long-term data. However, the final attrition rate was higher than the initially anticipated attrition rate (71% vs 40%).
Recommendations for Labeling Changes Labeling change is recommended to reflect the long-term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoint, follow-up visits etc.), final results, study strengths and limitations of the PAS.


OSB Lead-Chronic Lead Performance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3 month report 07/21/2009 07/21/2009 On Time
9 month report 01/07/2010 01/06/2010 On Time
15 month report 07/07/2010 07/06/2010 On Time
21 month report 01/07/2011 12/22/2010 On Time
27 month report 07/07/2011 06/28/2011 On Time
33 month report 01/07/2012 12/22/2011 On Time
39 month report 07/07/2012 06/28/2012 On Time
45 month report 01/07/2013 01/04/2013 On Time
month report 08/09/2013 08/08/2013 Overdue/Received
51 month report 01/07/2014 01/08/2014 Overdue/Received
non-scheduled non-clinical report 04/14/2014 04/14/2014 On Time
63 month report 07/07/2014 06/26/2014 On Time
69 month report 01/07/2015 12/18/2014 On Time
75 month report 07/07/2015 07/01/2015 On Time
81 month report 01/07/2016 12/22/2015 On Time
7 year report 07/07/2016 07/07/2016 On Time
93 month report 01/07/2017 01/11/2017 Overdue/Received
Final Report-interim report 04/07/2017 04/06/2017 On Time


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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