f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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 Intermediate Risk Cohort


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General
Study Status Ongoing
Application Number /
Requirement Number		 P130021 S033/ PAS001
Date Original Protocol Accepted 07/10/2017
Date Current Protocol Accepted 12/23/2023
Study Name Cont f/u Intermediate Risk Cohort
Device Name CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System
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 Objectives Continued follow-up of all living subjects who were enrolled in the SURTAVI trial under the IDE (G120169). The objective of this PAS is to characterize the clinical outcomes annually through 10 years post-procedure.
Study Population All living subjects who were enrolled in the IDE
Sample Size All living subjects
Key Study Endpoints The key safety and effectiveness endpoints include 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 f/u Intermediate Risk Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 01/08/2018 01/18/2018 Overdue/Received
2 year report 01/17/2019 01/17/2019 On Time
3 year report 01/17/2020 01/16/2020 On Time
4 year report 01/17/2021 01/15/2021 On Time
5 year report 01/17/2022 01/14/2022 On Time
6 year report 01/17/2023 01/17/2023 On Time
7 year report 01/17/2024 01/17/2024 On Time
8 year report 01/17/2025    


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

Additional Resources

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