Not yet recruitingOBSERVATIONAL

KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance

This study, called KONECTION, is looking at a new heart valve and artery replacement called KONECT RESILIA. It's for people aged 18 and older who need a new aortic valve because their old one isn't working properly, or they have a damaged part of their main heart artery (the aorta). Doctors will keep a close eye on up to 250 patients in the UK, Europe, and Canada to see how this new treatment performs in real-world situations. The aim is to understand its safety and effectiveness over time. This isn't a trial comparing it to another treatment, but rather observing how it works for patients who receive it as part of their standard care.

At a glance

Status

Not yet recruiting

Sponsor

Edwards Lifesciences

Enrolment target

250

Start

30 Jun 2026

Estimated completion

30 Jun 2039

Aortic Valve Disease

What is this study about?

When your aortic valve, one of the important valves in your heart, isn't working as it should, or if the main artery leaving your heart (called the aorta) is damaged, you might need an operation to fix it.

This study, called KONECTION, is looking at a specific device called the KONECT RESILIA aortic valved conduit. Think of it as a combined replacement part: it fixes your aortic valve and the damaged section of your aorta at the same time. Doctors want to see how well this device works and if it's safe for people in their everyday lives after they've had their operation. They will carefully follow up with patients who receive this particular device.

This is an 'observational study,' which means doctors aren't testing new medicines or different ways of operating. Instead, they are simply observing and gathering information from up to 250 patients who are already having this operation as part of their treatment. This will help them understand its long-term performance and safety in real-world situations.

Key takeaways

This study observes a combined heart valve and artery replacement device.
It's for people needing surgery on their aortic valve and a part of their aorta.
You must be 18 years or older to participate.
Data will be collected during your routine post-surgery check-ups.
The study aims to understand the device's safety and performance in real life.

Who may be eligible?

This study is looking for people who are 18 years old or older. You would be considered if your doctor has determined that you need to have your aortic valve replaced, and also need a section of your main artery (the aorta) repaired or replaced. Importantly, your doctor would need to plan to use the KONECT RESILIA device for this surgery.

There are certain situations where you wouldn't be able to join the study. For example, if you have an active heart infection, or if you needed emergency surgery. The study also wouldn't be suitable if you have severe kidney disease or require dialysis, or if doctors believe you have less than two years to live due to other serious health problems.

Also, if your predicted risk of serious complications from the heart surgery itself is very high (8% or more, as measured by a specific scoring system called STS-PROM), you wouldn't be included. This is because the study focuses on people where the surgery is considered to have a more typical risk.

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 18 years old or older?
Do you need surgery to replace your aortic valve and a part of your aorta?
Is your doctor planning to use the KONECT RESILIA device for your surgery?
Do you *not* have an active heart infection?
Is your surgery planned, not an emergency?
Do you *not* have severe kidney disease or require dialysis?

Answer every question to see your result.

What does participation involve?

If you join this study, it simply means that doctors will regularly collect information about your health and how the KONECT RESILIA device is performing after your surgery. This information would usually be gathered during your routine follow-up appointments with your heart specialist.

You won't be asked to take any different medications or have extra tests that you wouldn't normally have as part of your standard care. The study aims to observe your health and the device's performance over several years, collecting data during your usual clinical visits. The exact number and timing of these visits will depend on your doctor's usual practice for follow-up after this type of surgery.

Potential risks and benefits

Taking part in this study may not offer direct benefits to you personally, as it mainly involves observing your standard medical care. However, the information gathered will help doctors and researchers better understand the KONECT RESILIA device, potentially benefiting future patients. As with any medical procedure, there are always potential risks associated with the surgery itself. The study itself doesn't add new risks beyond what's already involved in your planned operation. You are free to withdraw from the study at any time without affecting the quality of your medical care.

Locations (1)

TUM Klinikum Deutsches Herzzentrum
Verified postcode
München, Germany

Common questions

What is an aortic valve?

The aortic valve is one of the four valves in your heart that helps control the flow of blood from your heart to the rest of your body.

What does a 'valved conduit' mean?

It means a special tube that replaces a section of your main artery (aorta) and also includes a new heart valve within it, all in one piece.

Is this a new type of operation?

No, you would be having an operation that your doctor has already decided is best for you. This study is just collecting information about this specific device used during that operation.

Will I have to do anything extra?

No, you won't need to make extra visits or change your medications. Information will be collected during your usual check-ups after your surgery.

Can I leave the study at any time?

Yes, you are free to stop participating in the study at any point, and your medical care will not be affected.

How to find out more

Sabrina Hundt, PhD

sabrina_hundt@edwards.com +49 (0)151 67550601 Official trial record

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