Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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...


           

Cont F/u of EARLY TAVR Premarket Cohort


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Study Pending
Application Number /
Requirement Number		 P140031 S182/ PAS001
Date Original Protocol Accepted 04/30/2025
Date Current Protocol Accepted  
Study Name Cont F/u of EARLY TAVR Premarket Cohort
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 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 5 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 death, all stroke, death or disabling stroke, hospitalization, new onset atrial fibrillation, New York Heart Association (NYHA) Functional Class, health status as evaluated by Kansas City Cardiomyopathy Questionnaire (KCCQ) score, hemodynamic valve performance and other echocardiographic parameters, and aortic valve intervention.
Follow-up Visits and Length of Follow-up 5 years


Cont F/u of EARLY TAVR Premarket Cohort 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
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

-
-