• 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...


           

SAPIEN 3 Ultra Novel Surveillance


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Ongoing
Application Number /
Requirement Number
P140031 S074/ PAS001
Date Original Protocol Accepted 12/27/2018
Date Current Protocol Accepted  
Study Name SAPIEN 3 Ultra Novel Surveillance
Device Name Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System
Clinical Trial Number(s) NCT03471065  
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Comprehensive/linked/registry-based surveillance. The objective of the surveillance is to assess the real-world use of the commercial SAPIEN 3 Ultra Transcatheter Heart Valve System for native aortic valve replacement in patients at intermediate and above surgical risk and for aortic and mitral valve-in-valve in patients at high and above surgical risk.
Study Population The surveillance will involve all consecutive patients treated within the first 2 years that are entered into the TVT Registry (enrollment period)
Sample Size All consecutive patients treated within the first 2 years in the commercial setting that are entered into the TVT Registry.
Key Study Endpoints The clinical data through one (1) year will be collected through the TVT Registry; and the follow-up data from year 2 through year 5 post procedure will be obtained through linking the TVT data with the Centers for Medicare and Medicaid Services (CMS) claims database. The surveillance will monitor the following: (1) device success (intra-procedure); (2) all-cause mortality, all stroke, life-threatening /major bleeding, new requirement for dialysis, peri-procedural myocardial infarction, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 30 days and 12 months; (3) neurological (non-stroke), vascular complications, and quality of life (KCCQ) outcomes at 30 days and 12 months; and (4) all-cause mortality, all stroke, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 2-5 year post-implantation.
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Interim Results Native:
1 year (TVT-R): all-cause death: 13.1%; all stroke: 3.3%; valve reintervention: 0.2%; KCCQ (mean change in summary score from baseline): 30.3 ± 0.33; NYHA (% in Class I/II): 91.6%; PVL = moderate: 1.5%; mean aortic gradient: 12.7 mmHg (compared to baseline mean gradient of 41.5 mmHg)
2-years (CMS-linked): all-cause death: 24.8%; all-stroke: 6.7%; valve re-intervention: 0.4%
Aortic THV-in-SV:
1 year (TVT-R): all-cause death: 14.6%; all stroke: 3.1%; valve reintervention: 2.9%; KCCQ (mean change in summary score from baseline): 37.9 ± 2.15; NYHA (% in Class I/II): 90.7%; PVL = moderate: 1.0%; mean aortic gradient: 18.8 mmHg (compared to baseline mean gradient of 36.6 mmHg)
2-years (CMS-linked): all-cause death: 23.5%; all-stroke: 6.6%; valve re-intervention: counts too small to report per data use agreement
Mitral THV-in-SV:
1 year (TVT-R): all-cause death: 18.9%; all stroke: 5.3%; valve reintervention: 0.6%; KCCQ (mean change in summary score from baseline): 40.5 ± 3.34; NYHA (% in Class I/II): 86.8%; PVL = moderate: 2.3%; mean mitral gradient: 8.0 mmHg (compared to baseline mean gradient of 14.2 mmHg)
2-years (CMS-linked): all-cause death: 28.6%; all-stroke and valve re-intervention: counts too small to report per data use agreement
Actual Number of Patients Enrolled Native: 14,226 patients (attempted); 14,096 patients implanted
Aortic THV-in-Surgical Valve: 492 patients (attempted); 486 patients were implanted
Mitral THV-in-Surgical Valve: 172 patients (attempted); 164 implanted
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate Native:
30 Days: Patient status known: 96.4%;
1 Year: Patient status known: 80.4%;
2 Years: 85.6% of eligible patients (11,608/13,562) matched within the CMS database. CMS data was available for 100% of matched patients at 2 years.
Aortic THV-in-SV:
30 Day: Patient status known: 96.3%;
1 Year: Patient status known: 79.7%;
2 Years: 84.8% of eligible patients (362/427) matched within the CMS database. CMS data was available for 100% of matched patients at 2 years.
Mitral THV-in-SV:
30 Day: Patient status known: 94.2%;
1 Year: Patient status known: 70.9%;
2 Years: 77.2% of eligible patients (112/145) matched within the CMS database. CMS data was available for 100% of matched patients at 2 years.


SAPIEN 3 Ultra Novel Surveillance Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 12/27/2019 12/23/2019 On Time
two year report 12/27/2020 12/15/2020 On Time
3 year report 12/27/2021 12/20/2021 On Time
4 year report 12/27/2022 01/30/2023 Overdue/Received
5 year report 12/27/2023 11/13/2023 On Time
6 year report 12/27/2024 11/14/2024 On Time
7 year report 12/27/2025    
8 year report 12/27/2026    
final report 12/27/2027    


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

-
-