Cardiovascular Research Institute of Kansas, LLC | Wichita, KS
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The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
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This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.
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915 participants in 2 patient groups
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Edwards THV Clinical Affairs
Data sourced from clinicaltrials.gov
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