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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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Cont F/u of REPRISE III Trial Premarket Cohorts

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Study Status Study Pending
Application Number P180029 / PAS001
Date Current Protocol Accepted  
Study Name Cont F/u of REPRISE III Trial Premarket Cohorts
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent 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 under the REPRISE III study protocol under IDE G140090. The objective of this PAS is to characterize the clinical outcomes annually through 5 years post-procedure.
Study Population Description All living subjects enrolled under the IDE (G140090) as part of the REPRISE III study
Sample Size All living subjects enrolled under the IDE (G140090) as part of the REPRISE III study
Data Collection The key safety and effectiveness endpoints include all-cause mortality, all-cause and disabling stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, major vascular complications, paravalvular aortic regurgitation, valve performance and durability, myocardial infarction, re-operation for valve-related dysfunction, rehospitalization for valve-related symptoms or worsening congestive heart failure, new permanent pacemaker implantation, new-onset atrial fibrillation, functional status as evaluated by New York Heart Association (NYHA) Class 5-meter gait speed test at 1 year, and health status as evaluated by Kansas City Cardiomyopathy Questionnaire (KCCQ) and SF-12 Quality of Life questionnaire at 1, 3, and 5 years.
Follow-up Visits and Length of Follow-up Visits will be conducted annually through 5 years post-procedure

Cont F/u of REPRISE III Trial Premarket Cohorts Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 04/22/2020 12/06/2019 On Time
two year report 04/22/2021    
three year report 04/22/2022    
four year report 04/22/2023    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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