The ALLIANCE trial
About the ALLIANCE trial
The ALLIANCE trial will evaluate if the SAPIEN X4S transcatheter heart valve (THV) is beneficial for patients with symptomatic, severe, calcific aortic stenosis. Talk to your doctor to determine if this trial is right for you.
Trial locations
You can find a participating hospital near you by visiting ClinicalTrials.gov.
If you have any questions about the trial, please contact our Patient Support Center.
What is symptomatic, severe, calcific aortic stenosis?
Your heart has four valves, that open and shut like doors, to help pump blood through your body. One of the four valves is called the aortic valve. The tissue from the valve, that opens and shuts like doors, are called leaflets. These leaflets can become stiff. The stiffness causes the opening of the valve to become smaller. This means the valve cannot fully open and shut like it should. As the opening becomes smaller, it makes it harder for the heart to pump blood, which can affect your health. This condition is called aortic stenosis.
Aortic stenosis is a progressive disease, which means it will get worse over time. Because of this, doctors will typically measure it as mild, moderate, or severe aortic stenosis. The stage of aortic stenosis depends on how damaged your aortic valve is. Severe aortic stenosis is the advanced case of aortic stenosis.
Disease progression in the valve leaflets in aortic stenosis
About the study device
Edwards SAPIEN X4S
Investigational Device
The Edwards SAPIEN X4S valve is an experimental, artificial heart valve that is made to replace your diseased aortic heart valve. Each valve consists of a metal frame with knitted fabric covering some of the frame. The frame has leaflets attached that are made of cow tissue and which open and close fully to direct the flow of blood through your heart the way your normal valve would if it were healthy. The device is implanted through the transcatheter aortic valve replacement (TAVR) procedure, which is minimally invasive and uses a catheter to implant a new valve through a small incision in your groin.
Edwards SAPIEN X4S
Investigational Device
If you agree to participate and are enrolled into this research study, your doctor will use the SAPIEN X4S transcatheter heart valve system to replace your valve. The study doctor has received extensive training on this SAPIEN X4S system by the manufacturer of the study device, Edwards Lifesciences. By participating in this trial, you may be able to help your doctors as well as helping others like yourself.
Eligibility criteria
- Severe, calcific aortic stenosis
- Native aortic annulus size suitable for SAPIEN X4 transcatheter heart valve
- New York Heart Association functional class ≥ II
- Full inclusion and exclusion criteria are detailed in the clinical protocol
Frequently Asked Questions
New medical devices are made available to people on a regular basis. However, they may need to be studied for how safe they are and how well they work. A clinical trial is a type of research conducted with volunteers that studies recently developed medical devices.
- Do you think transcatheter aortic valve replacement is an option for me?
- What are the possible risks and benefits of the TAVR procedure with the experimental Edwards SAPIEN X4 system in a failing aortic bioprosthetic valve?
- What additional screening tests will be done?
- How will the TAVR procedure be performed?
- What is the recovery time for TAVR?
- How often will I need to have follow-up visits?
- How long will this trial last?
Often patients are curious what is involved by participating in a clinical trial. While every experience is unique, you can expect the following milestones on your treatment journey. To participate, you must provide consent to your doctor.
- Your doctor will need to run some tests and collect imaging to determine the suitability of your heart for this device
- Your doctor will review your medications and medical history to see if you are eligible
- You will then be evaluated by a team of cardiology experts to determine if this is a treatment option for you
- If you qualify, you will undergo the TAVR procedure with the SAPIEN X4 valve
- All participants will be monitored throughout the clinical trial. This will require annual follow-up visits with your physician over a 10-year period
The tests or procedures required by the clinical trial, that would not otherwise be part of your standard care, will be covered by Edwards Lifesciences, the sponsor of this trial. You will still be responsible for the cost of your usual ongoing medical care, including deductibles and co-payments that would be billed to you or your health insurance provider.
Learn more about the procedure
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.
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CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.
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