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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 premarket cohort


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General
Study Status Progress Adequate
Application Number P140031 / PAS001
Date Current Protocol Accepted 08/19/2016
Study Name ODE Lead-Continued f/u of 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 all living subjects who were enrolled in the PIIS3HR cohort and Nested Registry #7 under the IDE. The objective of this PAS is to characterize the clinical outcomes annually through 5 years post-procedure.
Study Population Description All living subjects who were enrolled in the PIIS3HR cohort and Nested Registry #7 under the IDE
Sample Size All living subjects
Data Collection The safety and effectiveness endpoints include all-cause mortality, all stroke, total days alive and out of hospital (from date of index procedure), improvement per New York Heart Association (NYHA) Class (from baseline), improvement in 6 Minute Walk Test (at one year only), improvement per Kansas City Cardiomyopathy Questionnaire (KCCQ) and Euro Health Related Quality of Life (EQ5D), valve performance, major vascular complications, myocardial infarction, new permanent pacemaker, new onset atrial fibrillation, and bleeding.
Follow-up Visits and Length of Follow-up 5 years

All subjects are followed at 30 days, 6 months, 12 months, and annually thereafter through 5 years post procedure.



ODE Lead-Continued f/u of premarket cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 06/16/2016 06/13/2016 On Time
two year report 06/16/2017 06/13/2017 On Time
three year report 06/16/2018    
four year report 06/16/2019    
five year report 06/15/2020    


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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