Cobalt chromium frame
- Shared frame material designed for radial strength
- Similar frame heights
The ALLIANCE trial
One clinical program, multiple clinical trials
The ALLIANCE program consists of two clinical trials: The ALLIANCE trial (pivotal study) and the ALLIANCE aortic valve-in-valve (AViV) trial, each for a different patient condition.
About the ALLIANCE trial
The objective of the ALLIANCE trial (pivotal) is to establish the safety and effectiveness of the Edwards next-generation SAPIEN X4S valve in patients with symptomatic, severe, calcific aortic stenosis.
Contact our Patient Support Center to find your nearest participating hospital.
Study device
The SAPIEN X4S system's adjustable valve sizing and commissural alignment are being studied in this trial. The SAPIEN X4S system's adjustable valve sizing and commissural alignment are being studied in this trial. The SAPIEN X4S valve incorporates RESILIA tissue, which is created with a novel technology called Edwards Integrity Preservation.
Edwards SAPIEN X4S Valve
Investigational Device
Edwards SAPIEN X4S Valve
Investigational Device
SAPIEN X4S valve sizing
Each valve size can be deployed to five or six distinct diameters, offering 16 total size options across three valves
(0.5 mm increments)
Adjustable sizing can allow for more than one valve size to be selected for a given annulus area
Native annulus size - 3D area
Commissural alignment being studied
The SAPIEN X4S transcatheter heart valve system is designed with rotational alignment. It is being studied for its ability to align the THV commissures relative to the anatomy.
Valve features
Bovine pericardial tissue
- Both valves utilize RESILIA tissue which enables dry-storage and anti-calcification properties
- SAPIEN X4S valve leaflet design allows for full function across deployment range
Outer sealing skirt
- Shared PET outer sealing skirt material
- SAPIEN X4S valve skirt covers ~50% of the valve height
- SAPIEN X4S valve skirt designed to function across deployment range
CAUTION: The SAPIEN X4S valve is an INVESTIGATIONAL DEVICE. Limited by Federal (US) law to investigational use only. Comparison shown is illustrative only and does not establish safety, effectiveness, or equivalence for the SAPIEN X4S valve. See Instructions for Use for approved uses of the commercial SAPIEN 3 Ultra RESILIA valve.
RESILIA tissue platform
* Clinical data on surgical valves with RESILIA tissue up to 7-year follow-up have been published, with additional follow-up to 10-years in progress.1
RESILIA tissue is incorporated into the SAPIEN X4S valves under investigation.
Eligibility criteria
- Severe, calcific aortic stenosis
- Native aortic annulus size suitable for SAPIEN X4 THV
- NYHA functional class ≥ II
We’re here for you
We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center.
For details about the trial, visit NCT05172960 at ClinicalTrials.gov.
Give us a call
888.713.1564
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References
- Svensson L, Blackstone E, Bavaria J, et al. Long-term outcomes following aortic valve replacement with a novel tissue bioprosthesis: 10-year results from the COMMENCE trial. Abstract presented at: American Association for Thoracic Surgery (AATS) Annual Meeting; 2026.
CAUTION: Investigational device.
CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.
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