• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

Continued Follow-up of the SAPIEN 3


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Study Pending
Application Number /
Requirement Number
P140031 S162/ PAS002
Date Original Protocol Accepted 05/23/2024
Date Current Protocol Accepted  
Study Name Continued Follow-up of the SAPIEN 3
Device Name Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems
Clinical Trial Number(s) NCT03193801  
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Continued follow-up of premarket cohort
Study Population All living subjects who were enrolled in the IDE
Sample Size All living subjects
Key Study Endpoints The key safety and effectiveness endpoints include all-cause mortality, all stroke, myocardial infarction, valve reintervention, prosthetic valve endocarditis, prosthetic valve thrombosis, structural valve deterioration (SVD), New York Heart Association (NYHA) classification, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, hemodynamic performance metrics by Doppler echocardiography and adverse events.
Follow-up Visits and Length of Follow-up 10 years


Continued Follow-up of the SAPIEN 3 Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 05/23/2025    
2 year report 05/23/2026    
3 year report 05/23/2027    
4 year report 05/22/2028    
5 year report 05/22/2029    


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

-
-