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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 Progress Adequate
Application Number /
Requirement Number		 P130009 / PAS002
Date Original Protocol Accepted 06/16/2014
Date Current Protocol Accepted 06/16/2014
Study Name Comprehensive/Linked-Registry Based Surv
Device Name EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
Clinical Trial Number(s) NCT01314313 
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
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 severe native calcific aortic stenosis (aortic valve area < 1.0 cm2 or aortic valve area index < 0.6 cm2/m2, a mean aortic valve gradient of > 40 mmHg, or a peak aortic-jet velocity of > 4.0 m/s), and with native anatomy appropriate for the 23, 26, or 29 mm valve system, who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score > 8% or at a > 15% risk of mortality at 30 days).
Sample Size All implanted patients in the TVT-registry within 5 years of device approval.
Key Study Endpoints (1) device success (intra-procedure); (2) all-cause mortality, all stroke, life-threatening (or disabling) bleeding, acute kidney injury-stage 3 (including renal replacement therapy, acute events associated with index TAVR procedure), 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) annually through 5 year post implantation.
Follow-up Visits and Length of Follow-up 5 years
30 days, 12 months as per clinical practice; then annually up to 5 years through linking to CMS claims database.




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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