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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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 Registry-Based Cont Access & Low Risk RWU


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General
Study Status Study Pending
Application Number P140031 S085/ PAS002
Study Name SAPIEN 3 Registry-Based Cont Access & Low Risk RWU
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 Design Description Comprehensive/linked/registry-based surveillance. The objectives of the surveillance are to characterize the clinical outcomes of the CAP cohort annually through 10 years post implantation and to assess the real-world use of the commercial SAPIEN 3 Transcatheter Heart Valve System and SAPIEN 3 Ultra Transcatheter Heart Valve System to ensure that the device is used in appropriate circumstances.
Study Population Description The surveillance of the CAP cohort will consist of all living CAP patients who were enrolled at participating institutions, and the surveillance of the real-world use will involve all consecutive patients treated within the first 2 years that are entered into the TVT Registry (enrollment period)
Sample Size All living CAP subjects and all consecutive patients treated within the first 2 years in the commercial setting that are entered into the TVT Registry.
Data Collection The clinical data through one (1) year will be collected through the TVT Registry; and the follow-up data from year 2 through year 10 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 2-10 year post implantation.
Follow-up Visits and Length of Follow-up 10 years


SAPIEN 3 Registry-Based Cont Access & Low Risk RWU Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 09/01/2020    
two year report 09/01/2021    
three year report 09/01/2022    
four year report 09/01/2023    
five year report 09/01/2024    
six year report 09/01/2025    
seven year report 09/01/2025    
eight year report 09/01/2026    
nine year report 09/01/2027    
ten year report 09/01/2028    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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