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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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ODE Lead-Continued f/u of the premarket cohort


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General
Study Status Progress Adequate
Application Number P130009 S034/ PAS001
Date Current Protocol Accepted 08/19/2016
Study Name ODE Lead-Continued f/u of the premarket cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of premarket cohorts. The objective of this study is to characterize the cumulative clinical outcomes of all subjects at discharge or 7 days, whichever comes first, 30 days, 1 year, and annually thereafter through 5 years post procedure.
Study Population Description The study will consist of all living subjects who were enrolled in Nested Registry 3 under the IDE, including those enrolled under the continued access protocol.
Sample Size All living subjects
Data Collection The safety and effectiveness endpoints include all-cause mortality, all stroke, moderate or severe obstruction (defined as Doppler Velocity Index [DVI] < 0.25), or moderate or severe paravalvular leak (through 1 year only); all-cause mortality; all stroke or transient ischemic attack (TIA); all-cause mortality or major stroke; all stroke, major vascular complication, or aortic valve reintervention; New York Heart Association (NYHA) classification (additional data point at 6 months); change in 6-minute walk distance (6MWD) from baseline (through 1 year only); echocardiographic assessment of valve performance; clinical improvement per quality of life (QoL) instrument Kansas City Cardiomyopathy Questionnaire (KCCQ); and index hospitalization length of stay.
Follow-up Visits and Length of Follow-up 5 years

All subjects are followed at discharge or 7 days, whichever comes first, 30 days, 1 year, and annually thereafter through 5 years post procedure.



ODE Lead-Continued f/u of the premarket cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 10/08/2016 10/06/2016 On Time
two year report 09/12/2017 09/12/2017 On Time
three year report 09/12/2018    
four year report 09/12/2019    
five year report 09/12/2020    


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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