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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 Low Risk cohort PAS


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General
Study Status Ongoing
Application Number /
Requirement Number		 P140031 S085/ PAS001
Date Original Protocol Accepted 08/16/2019
Date Current Protocol Accepted  
Study Name Cont f/u of SAPIEN 3 Low Risk cohort PAS
Device Name SAPIEN 3 Ultra transcatheter heart valve
Clinical Trial Number(s) NCT02675114  
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 pivotal cohort under the IDE. 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 IDE pivotal cohort.
Sample Size All living subjects.
Key Study Endpoints All-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, requirement for renal replacement, 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, 6-Minute Walk Test (6MWT) distance, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and hemodynamic performance metrics by Doppler echocardiography.
Follow-up Visits and Length of Follow-up 10 years
Interim or Final Data Summary
Interim Results At 6 years:
All-cause mortality (including vital status check): 14.6% (TAVR); 11.9% (SAVR)
Stroke: 7.2% (TAVR); 6.6% (SAVR)
Aortic valve reintervention: 3.6% (TAVR); 3.6% (SAVR)
NYHA (% in class I/II): 94.9% (TAVR); 93.9% (SAVR)
KCCQ (Mean Change from Baseline): 13.2 (TAVR); 14.6 (SAVR)

At 5 years:
Transvalvular mean gradient: 12.8 (TAVR); 11.7 (SAVR)
Effective orifice area: 1.9 (TAVR); 1.8 (SAVR)
Greater than or equal to Moderate Total Aortic Regurgitation: 1.8% (TAVR); 0.3%
(SAVR)
Greater than or equal to Moderate PVL: 0.9% (TAVR); 0.0% (SAVR)
Actual Number of Patients Enrolled 1,000 randomized subjects; 948 implanted (495 TAVR & 453 SAVR)
Actual Number of Sites Enrolled 71
Patient Follow-up Rate At 6 years (patient status known): 89% (TAVR); 82% (SAVR)


Cont f/u of SAPIEN 3 Low Risk cohort PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/01/2020 09/02/2020 Overdue/Received
2 year report 09/01/2021 09/01/2021 On Time
3 year report 09/01/2022 09/01/2022 On Time
4 year report 09/01/2023 09/01/2023 On Time
5 year report 09/01/2024 08/30/2024 On Time
6 year report 09/01/2025 08/29/2025 On Time
7 year report 09/01/2026    
8 year report 09/01/2027    
9 year report 09/01/2028    
10 year report 09/01/2029    


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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