clinical trial · NCT06167213
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
Edwards Lifesciences·N/A·not yet recruiting·n = 125
Mitral RegurgitationMitral Valve DiseaseMitral StenosisSAPIEN X4 THV
brief 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.
started
Jan 1, 2027
primary completion
Mar 1, 2029
completion
Mar 1, 2038
last updated
Dec 22, 2025
detailed description
This is a prospective, single arm, multicenter, pivotal study.
official title
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve - Mitral
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol