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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 who are at high or greater risk with a failing aortic bioprosthetic valve.
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Prospective, single arm, multicenter study
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Interventional model
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200 participants in 2 patient groups
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Edwards THV Clinical Affairs
Data sourced from clinicaltrials.gov
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