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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 fu of Evolt R and PRO Sys Low Risk cohort PAS


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General
Study Status Progress Adequate
Application Number P130021 S058/ PAS001
Date Current Protocol Accepted  
Study Name Cont fu of Evolt R and PRO Sys Low Risk cohort PAS
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 in the pivotal cohort under the IDE. The objective of this study is to characterize the clinical outcomes annually through 10 years post-procedure.
Study Population Description All living subjects who were enrolled in the IDE pivotal cohort.
Sample Size All living subjects.
Data Collection All-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, acute kidney injury at stage 2 or 3, coronary artery obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure, new permanent pacemaker implantation, prosthetic valve endocarditis, prosthetic valve thrombosis, New York Heart Association (NYHA) classification, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and hemodynamic performance metrics by Doppler echocardiography.
Follow-up Visits and Length of Follow-up 10 years


Cont fu of Evolt R and PRO Sys Low Risk cohort PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 03/31/2020 03/31/2020 On Time
two year report 03/31/2021    
three year report 03/31/2022    
four year report 03/31/2023    
five year report 03/31/2024    
six year report 03/31/2025    
seven year report 03/31/2026    
eight year report 03/31/2027    
nine year report 01/15/2028    
ten year report 03/31/2029    


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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