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(for at least one location)
Describes the nature of a clinical study. Types include:
The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.
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Open for enrollment
This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.
The purpose of this study is to identify non-HLA and non-gal protein antigens in transplanted xenogenic tissues (ie bovine pericardial heart valves) that can then be used to preemptively identify and overcome graft-specific immune responses.
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