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ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral

Mitral Regurgitation Clinical Trial

Official title:
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve - Mitral

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

Clinical Trial Details
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
View Details
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