f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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SAPIEN 3 & SAPIEN 3 Ultra Mitral ValveInRing Surv


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General
Study Status Progress Adequate
Application Number /
Requirement Number		 P140031 S125/ PAS001
Date Original Protocol Accepted 05/13/2021
Date Current Protocol Accepted  
Study Name SAPIEN 3 & SAPIEN 3 Ultra Mitral ValveInRing Surv
Device Name SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System
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 Comprehensive/linked/registry-based surveillance. The objective of the surveillance is to continue to monitor the performance of the Edwards SAPIEN 3 and SAPIEN 3 Ultra THV System in the real-world setting.
Study Population Patients with symptomatic heart disease due to failing of a native mitral valve with an annuloplasty ring who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
Sample Size All consecutive patients treated within the first 5 years after the PMA approval that are entered into the TVT Registry.
Key Study Endpoints (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; and (3) neurological (non-stroke), vascular complications, and quality of life (KCCQ) outcomes at 30 days and 12 months.
Follow-up Visits and Length of Follow-up 1 year


SAPIEN 3 & SAPIEN 3 Ultra Mitral ValveInRing Surv Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 05/17/2022 05/09/2022 On Time
2 year report 05/17/2023    
3 year report 05/17/2024    
4 year report 05/17/2025    
5 year report 05/17/2026    
6 year report 05/17/2027    


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

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