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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-ATS 3f


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General
Application Number P060025 / PAS001
Current Plan Approved 10/13/2015
Study Name OSB Lead-ATS 3f
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 is a multi-center, non-randomized trial, registry study designed to follow at least 101 patients for 6 years (obtaining at least 606 patient years). The study will evaluate if there an increased incidence and risk of aortic regurgitation in a patient population 70 years of age or younger implanted with the ATS Medical, Inc., ATS 3f Aortic bioprosthesis, Model 1000 (Equine Pericardial bioprosthesis) undergoing isolated aortic valve replacement of his / her native aortic valve, or replacement of a failed prosthesis.
Study Population Description For patients undergoing isolated aortic valve replacement of his / her native aortic valve, or replacement of a failed prosthesis who are 70 years of age or younger at implant.
Sample Size 101 patients 70 years of age or less across 8 sites
Data Collection Hemodynamic performance, specifically the proportion of regurgitation, will be used to evaluate the safety of the valve. Hemodynamic performance will be evaluated with doppler echocardiographic studies at 3-6 months, 11-14 months and annually up to the 6 year postoperative evaluation. Values of mean gradient, peak gradient, EOA, EOA index (EOA/body surface area), performance index (EOA/pre-implant internal orifice area), CO, CO index, and valvular regurgitation will be presented.
Follow-up Visits and Length of Follow-up Patients will be enrolled and followed preoperative, operative, at discharge (or postoperatively at less than 30 days, whichever comes last), 3-6 months, 11-14 months and annually (plus/minus 2 months) thereafter until they reach the six years follow-up visit. Doppler echocardiography is required at 3-6 months, 11-14 months and annually up to the 6 year postoperative evaluation.
Final Study Results
Interim Safety Information A total of 5 patients have been enrolled and implanted with the study device. Three (3) incidences of regurgitation were reported: 2 perivalvular leaks and 1 nonstructural valve dysfunction - valve bioprosthesis mismatch.
Number of Patients 34; There were 26 eligible subjects implanted with the Model 1000 valve including 14 prospectively enrolled subjects and 12 retrospectively enrolled subjects.
Number of Sites 8
Follow-up Rate 90.9% at 4 years, 85.7% at 5 years
Safety Findings Adjudicated Events

Non Structural dysfunction 3, major perivalvular leak 3, Structural valve deterioration 2, Thromboembolism 5, bleeding event 1, severe respiratory sepsis with hypovolemic shock 1

Explants 6,



Other Events: Reoperation 3

Effect Findings Six (6) of 26 (23.1%) study subjects, experienced aortic regurgitation (AR) of moderate or greater severity. Among these 6 subjects, the moderate or greater regurgitation was transvalvular in 5 subjects and perivalvular in 1 subject, and these regurgitations required valve explant in 5 subjects.
Strengths & Weaknesses The study experienced difficulty with recruiting eligible subjects
Label Changes None


OSB Lead-ATS 3f Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 mth report 02/12/2010 02/04/2010 On Time
1 year report 08/12/2010 08/04/2010 On Time
18 mnth report 02/14/2011 02/11/2011 On Time
2 year report 08/12/2011 08/11/2011 On Time
30 month report 02/14/2012 02/14/2012 On Time
3 year report 08/13/2012 08/09/2012 On Time
42 month report 02/12/2013 02/08/2013 On Time
4 year report 08/12/2013 08/09/2013 On Time
54 month report 02/12/2014 02/07/2014 On Time
5 year report 08/12/2014 08/12/2014 On Time
66 month report 02/12/2015 02/12/2015 On Time
6 year report 08/12/2015 08/12/2015 On Time
Final Report 01/13/2016 01/13/2016 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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