Post-Approval Studies (PAS) Database

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

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
Clinical Trial Number(s)	NCT02675114
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
Interim or Final Data Summary
Interim Results	At 48 months: All-cause mortality: 7.3% All stroke (disabling and non-disabling): 4.2% Requirement for renal replacement: 0% Coronary Obstruction: 0% Aortic valve reintervention: 6% New permanent pacemaker implantation: 12.8% Prosthetic valve endocarditis: 3.1% Prosthetic valve thrombosis: 4.3% NYHA (% in class I/II): 98.1% KCCQ (Mean Change from Baseline): 19.0 Transvalvular mean gradient: 14.2 Effective orifice area: 1.9 Greater than or equal to Moderate Total Aortic Regurgitation: 1.9%
Actual Number of Patients Enrolled	75 enrolled; 71 implanted
Actual Number of Sites Enrolled	28
Patient Follow-up Rate	At 48 months (patient status known): 94%

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	08/30/2024	On Time
5 year report	09/01/2025

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background