Active not recruitingOBSERVATIONAL

Inspiris Resilia Durability Registry

This study is checking a new type of artificial heart valve called the INSPIRIS RESILIA Aortic Valve. It's for people aged 18 to 60 who are having surgery to fix a problem with their main heart valve (aortic valve stenosis). We want to see how well these new valves perform over five years after they've been put in. Doctors will be collecting information on how patients are doing, their heart health, and their quality of life. This is to make sure the valve is safe and works as expected in real-world situations, helping us understand its long-term benefits.

At a glance

Status

Active not recruiting

Sponsor

Institut für Pharmakologie und Präventive Medizin

Enrolment target

400

Start

26 Apr 2019

Estimated completion

01 Jul 2026

Aortic Valve Stenosis

What is this study about?

Imagine your heart has some very important doors, called valves, that help blood flow in the right direction. The aortic valve is like the main door for blood leaving your heart to go to the rest of your body. Sometimes, this door can become stiff and narrow, a condition called aortic valve stenosis. This makes your heart work much harder and can cause problems.

When this happens, doctors sometimes recommend surgery to replace the faulty valve with a new one. This study is looking at a specific new artificial heart valve called the INSPIRIS RESILIA Aortic Valve. It's made from specially treated animal tissue designed to last longer and work better. We want to see how patients, particularly those under 60, do with this new valve over a five-year period.

This study, called a registry, isn't testing a new drug but is observing how this already approved valve performs in many different hospitals across Europe. Doctors will collect details about how patients feel, how their heart is working, and generally their health and well-being. This helps us gather important information about the valve's long-term effectiveness and safety in everyday medical care.

Key takeaways

This study evaluates a new heart valve, INSPIRIS RESILIA, for younger patients.
It aims to see how well the valve works over a five-year period.
Participation involves routine follow-up appointments after surgery.
The study focuses on patients aged 18 to 60 needing aortic valve replacement.
This is a careful observation of the valve's real-world performance.
Your medical information will be collected to help improve future heart care.

Who may be eligible?

This study is for adults generally between 18 and 60 years old who need to have their main heart valve (aortic valve) replaced. You might also be having other heart surgery at the same time, like a bypass operation.

To join, you must be able to come to yearly check-ups at the hospital for up to five years after your surgery. You'll also need to understand and sign a consent form, agreeing to take part in the study.

However, you can't join if you have an active heart infection, or had one recently. Also, if you've had an aortic valve replacement before, or if your doctors believe you won't live for more than another year for other health reasons, this study wouldn't be suitable for you.

Quick self-check

Are you between 18 and 60 years old?
Do you need to have your main heart valve (aortic valve) replaced?
Can you attend yearly check-ups at the hospital for five years?
Do you NOT have an active heart infection?
Have you NOT had an aortic valve replacement before?
Do your doctors expect you to live longer than 12 months for other health reasons?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll have the new INSPIRIS RESILIA Aortic Valve implanted during your planned heart surgery. After your surgery, doctors will collect information about your health and feelings at various times. This includes before you leave the hospital, a few months later (between 3-6 months), and then once a year for up to five years.

During these regular check-ups, the medical team will likely ask you questions about your health and how you're feeling, and they might do some routine checks to see how your new valve is working. There are no extra medications to take for this study, just your usual prescribed medicines. The total duration of your participation, including all follow-up visits, would be five years.

Potential risks and benefits

Potential benefits of participating include receiving a new type of heart valve that is designed to potentially last longer and work more effectively. You would also be closely monitored by medical professionals over a five-year period, which could provide reassurance about your heart health. As with any surgery, there are risks associated with the valve replacement procedure itself, and these will be fully explained by your medical team. Also, like any medical device, there's always a small chance of unexpected problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (21)

University Clinics St. Pölten
Sankt Pölten, Austria
Heart Center Hietzing
Vienna, Austria
Medical University Vienna
Vienna, Austria
KU Leuven
Leuven, Belgium
Institut de Cardiologie de Montréal, Université de Montréal
Montreal, Canada
Laval University
Québec, Canada
Hopital de la Timone
Marseille, France
L'institut du thorax - CHU (Centre Hospitalier Universitaire de Nantes)
Nantes, France
Centre Hospitalier Universitaire (CHU) de Rennes
Rennes, France
CHRU - Hospital Trousseau
Tours, France
UNIVERSITÄTSKLINIKUM FREIBURG, Universitäts-Herzzentrum Herz- und Gefäßchirurgie
Freiburg im Breisgau, Germany
Heart Center Leipzig
Leipzig, Germany

+9 more sites — see the official record for the full list.

Common questions

What is aortic valve stenosis?

It's when the main valve in your heart, which controls blood flow to your body, becomes narrow and stiff, making your heart work harder.

What is the INSPIRIS RESILIA Aortic Valve made of?

It's a new heart valve made from specially treated animal tissue, designed to be more durable and long-lasting.

How long will I be followed in this study?

You will be followed up for five years after your surgery, with regular check-ups at the hospital.

Is this a new type of surgery?

No, it's a standard valve replacement surgery, but with a new type of artificial heart valve being implanted.

Can I leave the study at any time?

Yes, you can choose to stop participating in the study at any point without it affecting your medical care.