ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral (NCT06167213) | Clinical Trial Compass
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
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Non-hierarchical composite of death and stroke at 1 year
. 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