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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Comprehensive/Linked-Registry Based Surv


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General
Study Status Ongoing
Application Number /
Requirement Number		 P140031 S010/ PAS002
Study Name Comprehensive/Linked-Registry Based Surv
Device Name SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives To monitor the device performance in the post-approval setting through the national TVT-registry
Study Population Patients with symptomatic heart disease due to either severe native aortic stenosis who are deemed to be at intermediate or greater surgical risk, defined as having predicted risk of surgical mortality of = 3% at 30 days based on the STS risk score and other clinical co-morbidities not included in the STS risk score assessment.
Sample Size All implanted patients, with intermediate or greater risk for open surgical therapy, in the TVT-registry within five years of the device approval.
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; (3) neurological complications (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 years post implantation.
Follow-up Visits and Length of Follow-up 5 years




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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