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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 of SAPIEN 3 Bicuspid Registry


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General
Study Status Ongoing
Application Number /
Requirement Number		 P140031 S107/ PAS001
Date Original Protocol Accepted 07/22/2020
Date Current Protocol Accepted  
Study Name Cont f/u of SAPIEN 3 Bicuspid Registry
Device Name Sapien 3 and Sapien 3 Ultra Transcatheter Heart Valves
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Continued follow-up of all 71 subjects who were enrolled in the Bicuspid Registry under IDE G150278. The objective of this study is to characterize the clinical outcomes annually through 10 years post-procedure.
Study Population All living subjects who were enrolled in the Bicuspid Registry.
Sample Size 71
Key Study Endpoints All-cause mortality, all stroke (disabling and nondisabling), 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 - All subjects are followed annually through 10 years post procedure


Cont f/u of SAPIEN 3 Bicuspid Registry Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/01/2021 09/01/2021 On Time
2 year report 09/01/2022 09/01/2022 On Time
3 year report 09/01/2023 09/01/2023  
4 year report 09/01/2024    


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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