RecruitingOBSERVATIONAL

Post-Market Clinical Follow Up Study With Navitor Valve

This study, called 'VISTA Nova', is designed to check how safe and effective the Navitor TAVI System is for patients with aortic stenosis. This is a condition where the main valve leaving the heart, called the aortic valve, becomes stiff and doesn't open fully, making the heart work harder. The Navitor TAVI System is a new type of artificial heart valve that can be put in without major open-heart surgery. This study will follow patients who receive this valve to see how they get on over time. The main goal is to understand how well the Navitor valve performs in everyday use and how durable it is in the long term for people aged 18 to 100 years. It's an important step in making sure new medical devices are safe and work well for patients.

At a glance

Status

Recruiting

Sponsor

Abbott Medical Devices

Enrolment target

1,000

Start

29 Sep 2023

Estimated completion

01 Dec 2031

Aortic Stenosis

What is this study about?

When you have a condition called aortic stenosis, the main valve that controls blood flow from your heart to the rest of your body (the aortic valve) can become narrowed and stiff. This makes your heart work much harder to pump blood, which can lead to serious health problems. Replacing this faulty valve can improve symptoms and quality of life.

Traditionally, this has involved open-heart surgery. However, new techniques like Transcatheter Aortic Valve Implantation (TAVI) allow doctors to replace the valve using a much less invasive procedure, often through a small cut in the leg. This study is focusing on a specific new TAVI system called Navitor.

The 'VISTA Nova' study aims to check the Navitor valve in a practical, 'real-world' setting. It's like gathering feedback after a new product has been released to see how it performs with everyday use. Doctors want to understand how safe the Navitor valve is, how well it performs in helping people with aortic stenosis, and how long it lasts over time. This information is crucial for ensuring that the device continues to meet high standards for patient care.

Key takeaways

The study evaluates the Navitor TAVI System for treating aortic stenosis.
It aims to understand the safety and long-term performance of the new heart valve.
Participation involves receiving the Navitor valve and attending follow-up checks.
It's for adults with aortic stenosis who are suitable for this non-surgical valve replacement.
You'll receive close medical care and monitoring if you participate.

Who may be eligible?

This study is for adults generally aged between 18 and 100 years old, who are diagnosed with aortic stenosis. To be considered, a team of heart specialists will need to agree that the Navitor TAVI treatment is the right option for you according to current medical guidelines. You also need to be willing to come back for all the planned follow-up appointments after the procedure.

You wouldn't be able to join the study if the Navitor TAVI System isn't suitable for you based on its specific instructions for use. Also, if your doctors believe you have other serious health problems that might significantly shorten your life expectancy to less than a year, or if you have certain medical conditions that could make the treatment or follow-up difficult, you wouldn't be eligible. This includes if you can't have certain scans (like CT scans with dye) or if you can't take specific blood-thinning medications that might be required.

Finally, if your body's anatomy would make it very difficult or impossible to insert the new valve, or if you are already involved in another medical study that might affect the results of this one, you wouldn't be able to take part.

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.

Have you been diagnosed with aortic stenosis?
Has your heart team suggested TAVI as a treatment option for you?
Are you between 18 and 100 years old?
Are you willing and able to attend follow-up appointments after your procedure?
Are you able to have CT scans and take required medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a detailed discussion with the study team. You would then undergo the Navitor TAVI procedure as planned by your heart specialists. After the procedure, you will have several follow-up visits to check on your health and how the new valve is working. These visits might include various tests and check-ups, similar to what you would typically have after a heart valve replacement, but with specific timings for the study. The study team will explain the exact schedule of these visits and any specific tests involved. The total duration of your participation in terms of follow-up visits has not been specified but will be clearly communicated before you agree to take part.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of participating is that you would receive care from experienced heart specialists and have close monitoring of your health and the performance of your new heart valve. However, as with any medical procedure, there are risks associated with the TAVI procedure itself, such as bleeding, infection, or problems related to the new valve. The study is designed to gather more information on the Navitor valve, so there might be aspects that are still being understood. You will be given a full explanation of all known risks before deciding, and crucially, you have the right to withdraw from the study at any time without affecting your standard medical care.

Locations (35)

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

Royal Hobart Hospital
Verified postcode
Hobart, Australia· Recruiting
Clinique du Millénaire
Verified postcode
Montpellier, France· Recruiting
Mutualiste Montsouris
Verified postcode
Paris, France· Recruiting
CHRU Hopital de Pontchaillou
Verified postcode
Rennes, France· Recruiting
Clinique Pasteur Toulouse
Verified postcode
Toulouse, France· Recruiting
Herz- u. Gefäßzentrum Bad Bevensen
Verified postcode
Bad Bevensen, Germany· Recruiting
Deutsches Herzzentrum der Charité
Verified postcode
Berlin, Germany· Recruiting
St Johannes Hospital Dortmund
Verified postcode
Dortmund, Germany· Recruiting
Kliniken der Friedrich-Alexander-Universitat
Verified postcode
Erlangen, Germany· Recruiting
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Verified postcode
Frankfurt, Germany· Recruiting
UKE Hamburg
Verified postcode
Hamburg, Germany· Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Verified postcode
Kiel, Germany· Recruiting

Common questions

What is aortic stenosis?

Aortic stenosis is a condition where the main valve leaving your heart becomes stiff and doesn't open fully, making your heart work harder to pump blood.

What is the Navitor TAVI System?

It's a newer type of artificial heart valve that can be put into place using a less invasive procedure, often without major open-heart surgery.

Who can take part in this study?

Adults aged 18-100 with aortic stenosis, for whom the Navitor TAVI is considered suitable by their heart team, and who are able to attend follow-up appointments.

What does 'real-world setting' mean?

It means the study is looking at how the Navitor valve is working for everyday patients in standard clinical practice, rather than in a highly controlled experimental environment.

Can I leave the study if I change my mind?

Yes, you can choose to withdraw from the study at any time, and this will not affect the medical care you receive.

How to find out more

Bart Janssens

bart.janssens@abbott.com +32471723201 Official trial record

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