ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve (NCT05172960) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
United States, Australia, Canada1,234 participantsStarted 2022-06-20
Plain-language summary
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
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
. Severe, calcific AS
. Native aortic annulus size suitable for SAPIEN X4 THV
. NYHA functional class ≥ II
. 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
. Aortic valve is unicuspid, bicuspid or non-calcified
. Pre-existing mechanical or bioprosthetic valve in any position
. Severe aortic regurgitation (\> 3+)
. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis
. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
. Left ventricular ejection fraction \< 20%
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.
1This trial is studying the SAPIEN X4 transcatheter heart valve specifically for severe aortic stenosis — is my particular case of severe aortic stenosis the kind this device is designed to treat, and would I even be a candidate to discuss with the team?
2Since the trial is 'active not recruiting,' new patients can no longer enroll — but could my doctor still access the SAPIEN X4 through other means, like a commercial approval or a different study, if it seems like the right fit for me?
3The trial's main goal is to measure a combined rate of death and stroke — what does that tell us about the risk profile my doctor would want me to understand before considering this type of transcatheter valve procedure at all?
4This trial has no listed phase, which can mean it's a post-market or pivotal device study rather than an early experimental one — can my doctor explain what stage of evidence the SAPIEN X4 is at, and how confident they are in its safety and effectiveness based on what's been gathered so far?
5How does the SAPIEN X4 transcatheter approach compare to the standard treatments my doctor might already recommend for severe aortic stenosis, such as surgical valve replacement or other approved transcatheter valves, so I can understand whether this device would offer me anything different?
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.