Active not recruitingNAINTERVENTIONAL

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

This study is investigating a new type of artificial heart valve called SAPIEN X4 or SAPIEN X4S. It's designed for people in the UK with a specific and serious heart problem known as severe aortic stenosis. When someone has severe aortic stenosis, the main valve leaving their heart doesn't open properly, making it harder for blood to flow to the body. This study wants to confirm that these new SAPIEN heart valves are both safe to use and work well for these patients. It's a key step in helping to make new treatments available that could improve people's health and quality of life when they have this condition.

At a glance

Status

Active not recruiting

Phase

Sponsor

Edwards Lifesciences

Enrolment target

1,234

Start

20 Jun 2022

Estimated completion

01 Jan 2037

Aortic Stenosis, Severe

What is this study about?

This study is about a new artificial heart valve called the SAPIEN X4 or SAPIEN X4S. These valves are designed to help people who have a serious heart condition called severe aortic stenosis. This means the main valve leaving your heart (the aortic valve) has become stiff and doesn't open fully, making it difficult for your heart to pump blood around your body effectively. This can lead to symptoms like breathlessness, chest pain, and feeling tired.

The main goal of this study is to check how safe and effective these new SAPIEN heart valves are. 'Safe' means making sure there aren't too many serious problems when they are put in or afterwards. 'Effective' means checking that the valves open properly and help blood flow well from the heart. By doing this study, doctors hope to gather important information that could help many people with severe aortic stenosis in the future.

This study will involve several hospitals and clinics, and it will carefully follow people who receive the SAPIEN X4 or SAPIEN X4S valve. The information gathered will be looked at closely to understand the benefits and any potential drawbacks of using these new valves, aiming to improve treatment options for this heart condition.

Key takeaways

This study is testing a new artificial heart valve for severe aortic stenosis.
It aims to find out if the SAPIEN X4/X4S valve is safe and works well.
Participation involves medical assessments and follow-up after the valve procedure.
You must have severe aortic stenosis and symptoms to be considered.
You can stop participating at any time.
All study-related care is at no cost to you.

Who may be eligible?

To join this study, you would generally need to have severe aortic stenosis, which is a condition where your heart's main valve doesn't open properly. Your doctor would also check that the size of your heart's valve area is suitable for the SAPIEN X4 valve. You also need to be experiencing symptoms from your heart condition that affect your daily life, such as getting out of breath or tired easily. Importantly, you must be willing to learn about the study and agree to take part by signing a consent form.

There are also reasons why you might not be able to join. For example, if your arteries are too narrow for the delivery system that puts the new valve in, or if your aortic valve has an unusual shape or doesn't have calcium deposits. If you've had certain heart procedures recently, have other serious heart problems like severe leaks in other valves, or have had a heart attack or infection in your heart within a certain time, you might not be suitable. This is to make sure that the study is safe for everyone involved and that the results clearly show how well the SAPIEN X4 valve works for its intended purpose.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have severe aortic stenosis?
Are you currently having symptoms from your heart condition, like breathlessness or tiredness?
Are you comfortable understanding and signing consent forms?
Have you had a recent heart attack (within the last month)? (If yes, you may not be eligible.)
Do you have any other serious heart valve problems, like a very leaky valve, that would need treating soon?
Do your doctors think the SAPIEN X4 valve would fit your heart?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a thorough check-up to make sure you are suitable. This would involve various tests and scans, similar to what you might have before a heart procedure. After receiving the new heart valve, you would have regular follow-up appointments with the study team. These appointments would involve physical examinations, blood tests, and heart scans to monitor your health and how well the new valve is working. The study team will tell you exactly what visits and tests are needed. The overall duration of your participation in the study, including all follow-up, would be fully explained by the study team before you agree to take part.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as gaining access to a new heart valve that might improve your heart function and relieve your symptoms. However, like any medical procedure, there are potential risks involved. These might include risks related to the procedure itself, such as bleeding, infection, or issues with the heart valve. The study team will explain all known risks and potential benefits in detail. Remember, deciding to participate is entirely your choice, and you are free to withdraw from the study at any time without it affecting your usual medical care.

Locations (65)

Scripps Memorial Hospital La Jolla
Verified postcode
La Jolla, United States
Kaiser Los Angeles
Verified postcode
Los Angeles, United States
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States
Hoag Memorial Hospital Presbyterian
Verified postcode
Newport Beach, United States
UC Davis Medical Center Sacramento
Verified postcode
Sacramento, United States
Bay Area Structural Heart at Sutter Health
Verified postcode
San Francisco, United States
Kaiser San Francisco Medical Center
Verified postcode
San Francisco, United States
Stanford University
Verified postcode
Stanford, United States
UC Health Northern Colorado (Medical Center of the Rockies)
Verified postcode
Loveland, United States
Hartford Hospital
Verified postcode
Hartford, United States
Naples Community Hospital Healthcare System
Verified postcode
North Naples, United States
Piedmont Heart Institute
Verified postcode
Atlanta, United States

Common questions

What is severe aortic stenosis?

It's a serious heart condition where the main valve leaving your heart becomes stiff and narrow, making it hard for blood to flow to the rest of your body.

What is the SAPIEN X4 heart valve?

It's a new type of artificial heart valve designed to replace a diseased aortic valve without open-heart surgery, offering a less invasive treatment option.

Will I have to pay to be in the study?

No, you will not have to pay for your participation in the study. All study-related treatments and assessments are provided at no cost.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Who is running this study?

This study is sponsored by Edwards Lifesciences, a company that develops medical technologies for heart conditions.