Not Yet RecruitingNot Applicable

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

125 participantsStarted 2027-01

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

Exclusion criteria

✕. 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
✕. Annuloplasty ring dehiscence
✕. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \> 10 mmHg at the end of the index procedure for implantation of the original valve
✕. Annuloplasty ring type not favorable for THV implantation
✕. Increased risk of THV embolization

What they're measuring

Non-hierarchical composite of death and stroke at 1 year

Timeframe: 1 year

Trial details

NCT IDNCT06167213

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-03

Contact for this trial

Edwards THV Clinical Affairs

949-250-2500 THV_CT.gov@edwards.com

View on ClinicalTrials.gov More Mitral Regurgitation trials