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 Low Risk cohort PAS

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: At least 22 yrs
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 8 years: All-cause mortality (including vital status check): 26.5% [22.8, 30.8]* (TAVR); 22.2% [18.5, 26.5]* (SAVR) - KM Stroke: 9.4% [7.0, 12.6]* (TAVR); 8.2% [5.9, 11.4]* (SAVR) - KM Aortic valve reintervention: 7.3% [5.2, 9.9]* (TAVR); 6.8% [4.6, 9.6]* (SAVR) - CIF NYHA (% in class I/II): 95.1% (TAVR); 95.4% (SAVR) KCCQ (Mean Change from Baseline): 12.3 (TAVR); 13.9 (SAVR) At 7 years: Bioprosthetic valve failure: 6.9% [4.8, 9.4]* (TAVR); 7.5% (SAVR) [5.2, 10.4]* - CIF Transvalvular mean gradient: 13.3 (TAVR); 12.1 (SAVR) Effective orifice area: 1.9 (TAVR); 1.8 (SAVR) Greater than or equal to moderate total aortic regurgitation: 2.4% (TAVR); 1.6% (SAVR) Greater than or equal to moderate PVL: 1.0% (TAVR); 0.4% (SAVR) *Confidence Interval
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 8 years (patient status known): 89.7% (TAVR); 80.4% (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	08/31/2026	On Time
8 year report	09/01/2027
9 year report	09/01/2028
10 year report	09/01/2029

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