Active not recruitingOBSERVATIONAL

NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population

This study is gathering real-world information about a new way to replace a faulty heart valve called the ALLEGRA TAVI System TF. It focuses on people in the UK whose original heart valve has become stiff and calcified, or who have had a surgical valve replacement that's no longer working correctly. Researchers want to see how patients are doing after getting this new valve, checking their overall health and how it affects their daily lives, both shortly after the procedure and in the months that follow. The aim is to understand the benefits and challenges of this treatment in a typical patient population.

At a glance

Status

Active not recruiting

Sponsor

NVT GmbH

Enrolment target

346

Start

20 Feb 2019

Estimated completion

26 Jan 2029

Transcatheter Aortic Valve Implantation

What is this study about?

This research is looking into a new type of heart valve replacement called the ALLEGRA TAVI System TF. TAVI stands for Transcatheter Aortic Valve Implantation, which is a less invasive way to replace a faulty heart valve compared to traditional open-heart surgery. Instead of opening the chest, doctors insert the new valve using a thin tube called a catheter, usually through a blood vessel in the leg.

The study aims to understand how well this particular ALLEGRA TAVI system works for people in their everyday lives. It's collecting information on patients who have already received this treatment for serious problems with their aortic heart valve. This includes people whose natural valve has hardened and narrowed due to calcium build-up, or those who have an older, surgically implanted valve that is no longer working properly. The medical team believes these patients are at high risk for traditional surgery, making TAVI a more suitable option.

By following these patients over time, the researchers will gather important details about how their health is improving, what their quality of life is like, and any challenges that might arise. This 'real-world data' is crucial because it helps doctors and patients make informed decisions about heart valve treatments in the future.

Key takeaways

This study evaluates a less invasive heart valve replacement (TAVI).
It's for people with serious aortic valve problems who are high-risk for surgery.
The study collects 'real-world' information on patient health and quality of life.
You won't receive extra medication; participation involves data collection during your care.
The goal is to better understand how the ALLEGRA TAVI system works for patients.

Who may be eligible?

To be considered for this study, you would typically have a problem with your aortic heart valve that is causing symptoms. This means your natural valve might be significantly hardened and not working well, or you could have a previously implanted surgical valve that has stopped working correctly. Critically, your healthcare team would need to agree that the ALLEGRA TAVI treatment is a good option for you, and that open-heart surgery carries too many risks.

There are also some reasons why you might not be able to join the study. For example, if you have blood clots in your heart, certain severe problems with your blood vessels that would make inserting the new valve difficult, or severe kidney failure requiring dialysis, you wouldn't be eligible. Also, if you have an active infection, a very weak heart (with an LVEF below 20%), or another serious illness that means you're not expected to live more than 12 months, you wouldn't be able to participate.

Other specific conditions that might exclude you include certain types of abnormal aortic valves (like a unicuspid or bicuspid valve), severe leakage rather than narrowing of the valve, or if your heart's anatomy isn't suitable for the device. If you've had a previous valve replacement, certain sizes or specific issues with the old valve might also mean you can't take part. You also shouldn't be involved in another medical study at the same time.

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 a heart valve problem causing symptoms?
Has your heart team said you are high-risk for open-heart surgery?
Are you able to safely receive the ALLEGRA TAVI system?
Do you have any severe kidney problems or active infections?
Are you participating in another medical research study currently?

Answer every question to see your result.

What does participation involve?

If you are part of this study, you will receive the ALLEGRA TAVI System TF as your treatment. The study involves collecting information about your health and quality of life after the procedure. This will include follow-up visits with your medical team to check on your progress. You will have assessments to see how your heart is working and how you are feeling generally. The total duration of your participation in terms of data collection will cover the early period after your procedure and extend to mid-term follow-ups. You wouldn't be asked to take any additional medication specifically for the study beyond what your doctors prescribe for your heart condition.

Potential risks and benefits

Like any medical procedure, there are potential benefits and risks to be aware of. The potential benefit of the ALLEGRA TAVI system is to improve your heart's function and your overall quality of life if you have a faulty heart valve and are considered high-risk for traditional surgery. Potential risks are associated with any heart valve procedure, including complications from the insertion of the device, allergic reactions to materials or contrast dyes, and although rare, serious events. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (14)

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

Oulu University Hospital
Verified postcode
Oulu, Finland
Herz- und Gefäßzentrum Bad Bevensen
Verified postcode
Bad Bevensen, Germany
Schuechtermann-klinik
Verified postcode
Bad Rothenfelde, Germany
Kath. Marienkrankenhaus
Verified postcode
Hamburg, Germany
MH Hannover
Verified postcode
Hanover, Germany
SLK-Kliniken Heilbronn
Verified postcode
Heilbronn, Germany
Ospedale San Raffaele
Verified postcode
Milan, Italy
Clinica Mediterranea Neapel
Verified postcode
Naples, Italy
Heartcentre Catharina Hospital Eindhoven
Verified postcode
Eindhoven, Netherlands
Hospital Universitario La Paz
Verified postcode
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Verified postcode
Málaga, Spain
Hospital Universitario de Salamanca
Verified postcode
Salamanca, Spain

Common questions

What is the ALLEGRA TAVI System TF?

It's a new type of artificial heart valve used to replace a diseased aortic valve through a less invasive procedure, typically inserted through a blood vessel.

Who is this study for?

It's for people with a serious problem with their aortic heart valve who are considered too high-risk for traditional open-heart surgery.

What kind of information will be collected?

Researchers will gather data on your health status and how the treatment affects your daily life (quality of life) after receiving the new valve.

Is this a new treatment, or has it been used before?

The ALLEGRA TAVI System TF is an approved treatment, and this study is collecting real-world data from patients who are already receiving it as part of their care.

Will I have to do anything extra if I'm in this study?

Your participation involves allowing researchers to collect details about your health and recovery during your regular follow-up appointments after receiving the valve.