ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEdwards Lifesciences
About this trial
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.
Eligibility criteria
Qualifiers
Failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
Bioprosthetic surgical valve or native mitral annulus size suitable for SAPIEN X4 THV
NYHA functional class ≥ II
Heart Team agrees the subject is at high or greater surgical risk
Disqualifiers
Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
Interatrial septum or left atrium not suitable for transcatheter transseptal access
Failing valve has mild or greater paravalvular regurgitation
Failing valve is unstable, rocking, or not structurally intact
Trial design
Treatments tested in this trial
- SAPIEN X4 THV
Treatment groups
125 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov