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Clinical Trial Summary

This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring.


Clinical Trial Description

This is a prospective, single arm, multicenter, pivotal study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06167213
Study type Interventional
Source Edwards Lifesciences
Contact Edwards THV Clinical Affairs
Phone 949-250-2500
Email THV_CT.gov@edwards.com
Status Not yet recruiting
Phase N/A
Start date September 2024
Completion date March 2038

See also
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