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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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Trifecta Valve PAS

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Study Status Completed
Application Number P100029 / PAS001
Date Current Protocol Accepted 04/20/2011
Study Name Trifecta Valve PAS
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 multi-center, prospective, non-randomized,
post-approval study conducted in the United States
Study Population Description Subjects previously implanted with a Trifecta prosthetic valve at the selected sites during the IDE clinical investigational study and meet all eligibility criteria for this clinical study will be invited to participate.
Sample Size The study will enroll approximately 300 subjects enrolled from approximately 6 U.S. sites that enrolled subjects in the Trifecta¿ valve IDE study to result in a minimum of one-hundred-sixty (160) subjects followed for five (5) years from their Trifecta implant procedure.
Data Collection Primary Endpoints: Late endocarditis and embolism (linearized) rates as compared to the FDA Draft Replacement Heart Valve Guidance Objective Performance Criteria (OPC).

Secondary Endpoints: valve thrombosis, major bleed, all

paravalvular leak, major paravalvular leak, reoperation, explants,

non-structural dysfunction, structural deterioration, valve related

death, embolism, endocarditis, valve thrombosis, major bleed, all paravalvular leak, major paravalvular leak, reoperation, explants, nonstructural dysfunction, structural deterioration and valve-related death, New York Heart Association (NYHA) functional classification status at each interval, and hemodynamic performance at each interval.

Follow-up Visits and Length of Follow-up Five-years post implant

Interim or Final Data Summary
Actual Number of Patients Enrolled 245
Actual Number of Sites Enrolled 6
Patient Follow-up Rate 94.7%
Final Safety Findings No Unanticipated Adverse Device Effects (UADE¿s) was reported during the continued follow-up study period. The linearized thromboembolism and endocarditis rates are statistically significantly lower than the FDA 1994 Draft Replacement Heart Valve Guidance Objective Performance Criteria (OPC).
Final Effect Findings At 5-year visit, over 90% patients maintained at NYHA I level, and valve insufficiency was classified as either none, trivial, or mild for 98.2% of patients.
Study Strengths & Weaknesses Strength: long-term follow-up (5 years) with over 94.7% of follow-up rate

Weakness: The study population consisted of subjects from the premarket cohort. Premarket studies

are typically characterized by providers who are exceptionally skilled; and are therefore likely to provide relatively good results
Recommendations for Labeling Changes Because neither safety nor effectiveness data presented in the final report substantially alter the labeling already approved for the Trifecta Valve, the labeling updates for Trifecta Valve is not recommended

Trifecta Valve PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 10/19/2011 10/18/2011 On Time
one year report 04/19/2012 04/18/2012 On Time
18 month report 10/18/2012 10/16/2012 On Time
two year report 04/19/2013 04/16/2013 On Time
three year report 04/19/2014 04/16/2014 On Time
final report 10/31/2014 10/28/2014 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

Phone: (301) 796-6134
Fax: (301) 847-8140

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