Active not recruitingOBSERVATIONAL

SAPIEN 3 Ultra System PMCF

This study is about a new heart valve called the SAPIEN 3 Ultra System. Doctors use this valve to treat a condition called aortic stenosis, where the main valve in your heart doesn't open properly, making it harder for your heart to pump blood. This study aims to check how well this new valve works and how safe it is after it's been used in real patients. It's like a long-term check-up to make sure the valve continues to perform as expected in people who have received it. The information gathered will help doctors understand more about this treatment and how it benefits patients over time.

At a glance

Status

Active not recruiting

Sponsor

Edwards Lifesciences

Enrolment target

200

Start

30 Jun 2020

Estimated completion

01 Nov 2026

Aortic Valve Stenosis

What is this study about?

This study is focused on a specific medical device called the SAPIEN 3 Ultra System, which is a replacement heart valve. It's used to treat a condition called 'aortic valve stenosis,' which means the main valve in your heart (the aortic valve) has become stiff and narrow. This makes it difficult for your heart to pump blood out to your body, leading to symptoms like chest pain, breathlessness, and tiredness.

The main purpose of this study is to keep a close eye on how well this new SAPIEN 3 Ultra heart valve performs once it's been implanted in patients. It's often called a 'post-market' study because it happens after the device has already been approved for use. Researchers want to gather real-world information about its safety and how effectively it helps patients over time. This helps doctors and medical companies ensure that the treatment continues to be beneficial for patients.

By carefully watching how people with the SAPIEN 3 Ultra valve get on, the study aims to make sure that the treatment is working as expected and to identify any areas where it could be improved. This ongoing monitoring is a crucial part of medical care, ensuring that new treatments are not only safe but also truly make a positive difference to people's health and quality of life.

Key takeaways

This study evaluates an existing heart valve (SAPIEN 3 Ultra System).
It's for people with severe aortic valve stenosis.
The study monitors the valve's performance and safety over time.
Participation involves regular medical check-ups.
It aims to gather real-world data for long-term understanding.
You can withdraw at any time without affecting your care.

Who may be eligible?

To be considered for this study, your doctors (often a team of heart specialists) must have decided that you have severe aortic stenosis. This means the main valve in your heart is very narrow and causing noticeable symptoms.

Importantly, your heart team must also believe that having open-heart surgery to replace the valve would be either a moderate or high-risk procedure for you. This study is specifically for people where traditional surgery might be too risky.

There are also some reasons why you might not be able to join. For example, if you have a blood clot in your heart, certain infections, or if you cannot take blood-thinning medicines, this study might not be suitable for you. You will also need to understand and agree to all the study procedures by signing a consent form.

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.

I have been diagnosed with severe aortic valve stenosis.
My heart team believes open-heart surgery is a high or moderate risk for me.
I don't have a blood clot or active infection in my heart.
I am able to take blood-thinning or antiplatelet medications if needed.
I am prepared to attend all required follow-up appointments.
I understand and am willing to sign a consent form.

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be given a new medicine or treatment that hasn't been used before. Instead, you'll be receiving the SAPIEN 3 Ultra heart valve as part of your normal care for aortic stenosis. The study involves closely monitoring your health and how the valve is performing over time.

This will include regular check-ups with your doctors, which might involve physical examinations, blood tests, and imaging scans (like echocardiograms) to check your heart and the new valve. These visits and tests are mostly what you would expect after having a heart valve replacement, but they may be scheduled more regularly or specifically for the study. The total duration of your participation, including all follow-up visits, would be explained to you in detail by the study team.

Potential risks and benefits

The main benefit of participating is that you would receive the SAPIEN 3 Ultra heart valve, which is an established treatment for severe aortic stenosis, helping to improve your heart function and relieve symptoms. However, as with any medical procedure, there are potential risks associated with implanting a heart valve, such as bleeding, infection, or complications related to the procedure itself. Your doctor will discuss these general risks with you. Taking part in the study means your health will be carefully monitored, which can be an added reassurance. You are free to withdraw from the study at any time without affecting your medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Medizinische Universitaet Wien
Verified postcode
Vienna, Austria
St. Paul's Hospital Vancouver
Verified postcode
Vancouver, Canada
Aarhus University Hospital, Skejby
Verified postcode
Aarhus, Denmark
Helsinki University Hospital
Verified postcode
Helsinki, Finland
Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany
Deutsches Herzzentrum Berlin
Verified postcode
Berlin, Germany
Universitares Herzzentrum Hamburg
Verified postcode
Hamburg, Germany
Ospedale G. Pasquinucci
Verified postcode
Massa, Italy
Universitair Medisch Centrum Utrecht
Verified postcode
Utrecht, Netherlands
Royal Victoria Hospital Belfast
Verified postcode
Belfast, United Kingdom
King's College Hospital London
Verified postcode
London, United Kingdom

Common questions

What is Aortic Valve Stenosis?

It's a condition where the main valve in your heart (the aortic valve) doesn't open fully, making it harder for blood to leave your heart and go to your body. This can make you feel breathless or tired.

What is the SAPIEN 3 Ultra System?

It's a type of replacement heart valve that can be put into your body without needing open-heart surgery, often through a small cut in your leg or chest.

Why is this study happening?

This study is designed to check how well the SAPIEN 3 Ultra heart valve continues to work and how safe it is for patients after it has been used in real-world settings. It helps doctors learn more about the long-term effects.

Will I get a special treatment if I join?

No, you would receive the SAPIEN 3 Ultra heart valve as a standard treatment for your condition. The study is about carefully watching how people who get this valve get on, rather than testing a new, untried treatment.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point, and this will not affect the medical care you receive.