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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Registry-Based Real-World Use Surveillance

General
Study Status	Study Pending
Application Number / Requirement Number	P140031 S182/ PAS002
Date Original Protocol Accepted	04/30/2025
Date Current Protocol Accepted
Study Name	Registry-Based Real-World Use Surveillance
Device Name	Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system
Clinical Trial Number(s)	NCT03042104
General Study Protocol Parameters
Study Design	Active Surveillance
Data Source	External Registry
Comparison Group	Historical Control
Analysis Type	Descriptive
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	Registry-Based Real-World Use Surveillance. The objective of the surveillance is to assess the real-world performance of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA THV System and the clinical outcomes of the device in patient populations under-enrolled in the pivotal trial.
Study Population	Patients with asymptomatic severe native calcific aortic stenosis who are judged by a heart team to be appropriate for transcatheter heart valve replacement therapy.
Sample Size	All consecutive patients treated within the first 2 years following device approval or a total of 2,000 consecutively treated patients, whichever is greater, who are entered into the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry. Data collection will continue for under-enrolled racial and ethnic groups until each group has enrolled a minimum number of patients as specified: Black/African American, 100; Asian, 100, American Indian/Alaskan Native, 50, Native Hawaiian/Pacific Islander, 50; and Hispanic or Latino ethnicity, 100. Data collection will also continue for under-enrolled patients deemed to be at intermediate or greater risk for open surgical therapy until a minimum of 300 patients have been enrolled.
Key Study Endpoints	The clinical data through one (1) year will be collected through the TVT Registry. The follow-up data (including all-cause mortality, all stroke, and aortic valve reintervention) from year 2 through year 5 post-procedure will be obtained through linking the TVT Registry data with the Centers for Medicare and Medicaid Services (CMS) claims database.
Follow-up Visits and Length of Follow-up	5 years

Registry-Based Real-World Use Surveillance Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	04/30/2026
2 year report	04/30/2027
3 year report	04/29/2028
4 year report	04/29/2029

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