Not yet recruitingOBSERVATIONAL

Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve

This study is investigating a new heart valve called the SAPIEN 3 Ultra RESILIA. This valve is used in a procedure called Transcatheter Aortic Valve Replacement (TAVR) for people with common heart valve issues like aortic stenosis, where the valve narrows, or aortic insufficiency, where it doesn't close properly, or other degenerative valve disease. The main goal is to closely watch the performance of this new valve over 10 years. Doctors want to understand how long the valve lasts, how well it works, and how it impacts patients' overall health. This information is important because more and more people are having these procedures, and doctors want to ensure the valves continue to work well for many years, especially for younger patients who are living longer after their treatment.

At a glance

Status

Not yet recruiting

Sponsor

Institut für Pharmakologie und Präventive Medizin

Enrolment target

500

Start

01 Mar 2026

Estimated completion

30 Sep 2037

Transcatheter Aortic Valve Replacement (TAVR)Aortic-Stenosis Aortic Insufficiency Degenerative Valve Disease

What is this study about?

Imagine your heart has a very important door, called the aortic valve, that opens and closes to let blood flow out to your body. Sometimes this door can get stiff and narrow (called aortic stenosis) or not close properly (aortic insufficiency), making it harder for your heart to pump blood. When this happens, doctors sometimes recommend a procedure to replace this faulty valve with a new one.

Traditionally, valve replacement meant open-heart surgery. However, there's a newer, less invasive method called Transcatheter Aortic Valve Replacement (TAVR). Instead of a large incision, doctors can now insert a new valve through a small tube, usually through an artery in your leg, and guide it to your heart. This study is focusing on a specific type of new valve used in TAVR, called the SAPIEN 3 Ultra RESILIA.

The main aim of this study is to see how well this particular SAPIEN 3 Ultra RESILIA valve performs over a long period – up to 10 years. Doctors are especially interested in how durable the valve is, meaning how long it lasts and continues to work effectively without problems. This is important because more and more people who are a bit younger are now having TAVR, and they often live many years after the procedure. Understanding the long-term performance of these valves is key to ensuring patients have the best possible outcomes for many years to come.

Key takeaways

This study is about a new heart valve (SAPIEN 3 Ultra RESILIA) used in TAVR.
It aims to check how well the valve works over 10 years.
It's for adults with severe aortic valve problems having a TAVR procedure.
Regular follow-up appointments for up to 10 years are required.
The goal is to understand the valve's long-term performance for patients living longer after this treatment.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older. You would also have severe narrowing of your aortic valve (aortic stenosis) and be scheduled to have a TAVR procedure using the SAPIEN 3 Ultra RESILIA valve.

It's very important that you are willing and able to attend all the follow-up appointments for up to 10 years at the hospital where you have your procedure. This commitment helps researchers collect all the necessary information about the valve's performance over time.

You would not be able to join the study if you need an emergency procedure, if you are pregnant, or if you are unable to give your written consent to participate. The study also focuses on people whose TAVR procedure goes smoothly and without severe complications right away, helping doctors to clearly see how the valve itself performs over the long term.

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.

Are you an adult (18 years or older)?
Do you have severe aortic stenosis?
Are you scheduled for a TAVR procedure using the SAPIEN 3 Ultra RESILIA valve?
Are you willing and able to attend follow-up visits for up to 10 years?
Are you not currently pregnant or needing an emergency heart procedure?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the SAPIEN 3 Ultra RESILIA heart valve as part of your TAVR procedure. After your procedure, you would need to attend regular follow-up visits at the hospital. These visits are crucial for the researchers to monitor how your new valve is working and how you are recovering and living your life.

These follow-up appointments will continue for a long time, up to 10 years after your heart valve replacement. During these visits, doctors will likely perform various checks and tests, though the exact details aren't fully described here. The goal is to carefully observe the valve's performance and your overall health during this decade-long period. You will continue to receive your usual medical care and any prescribed medications throughout the study period.

Potential risks and benefits

Taking part in this study means you would receive the SAPIEN 3 Ultra RESILIA valve, which is designed to improve your heart's function if you have severe aortic valve disease. The potential benefit is that this valve may offer excellent long-term performance, giving you confidence in your treatment. As with any medical procedure, there are potential risks associated with the TAVR procedure itself, including risks of bleeding, stroke, or problems with the new valve, which your doctor will discuss with you. Any new heart valve also carries a very small, unknown risk of long-term issues that researchers are trying to understand. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Heart and Diabetes Center North Rhine-Westphalia
Verified postcode
Bad Oeynhausen, Germany

Common questions

What is aortic stenosis?

Aortic stenosis is when the main valve in your heart, called the aortic valve, becomes stiff and narrows. This makes it harder for your heart to pump blood out to your body.

What is a TAVR procedure?

TAVR stands for Transcatheter Aortic Valve Replacement. It's a way to replace a faulty heart valve using a small tube inserted through a blood vessel, usually in your leg, instead of open-heart surgery.

Why is this study important for me?

This study is looking at how a specific new heart valve works over many years. If you are having a TAVR procedure, this research helps doctors understand if this valve will be a good, long-lasting option for people like you.

How long will I be followed in the study?

If you participate, the research team will follow your health and the performance of your new valve for up to 10 years after your TAVR procedure.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time without it affecting the medical care you receive from your doctors.

How to find out more

Claudia Lüske, PhD

claudia.lueske@ippmed.de 044718503324 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.