Active not recruitingNAINTERVENTIONAL

Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

This study is testing a new heart valve called NAVITOR for people who have severe aortic stenosis. Aortic stenosis is a condition where the main valve letting blood out of your heart, the aortic valve, becomes stiff and doesn't open wide enough. This can make you feel tired or short of breath. The NAVITOR valve is put into place using a special procedure called TAVR, which doesn't involve open-heart surgery. Researchers want to find out how safe and well this new valve works in patients who are considered to have a low or medium risk for traditional surgery. They are also looking at how well it works if you already have an artificial valve that needs replacing.

At a glance

Status

Active not recruiting

Phase

Sponsor

Abbott Medical Devices

Enrolment target

434

Start

13 Jul 2021

Estimated completion

28 Feb 2036

Symptomatic Severe Aortic Stenosis

Results

Results from this study

Posted April 2026

Results have been published for this study.

Primary outcome

Primary Effectiveness Endpoint: Percentage of Participants With Moderate or Greater Paravalvular Leak (PVL)

The primary effectiveness endpoint is moderate or greater paravalvular leak (PVL) at 30 days, as assessed by the echocardiographic core laboratory. The hypothesis test was performed based on the implanted population in whom a functional Navitor valve remained implanted at 30 days.

Full results on the registry

What is this study about?

This study, called VANTAGE, is looking at a new medical device called the NAVITOR valve. This valve is designed to help people who have a serious heart condition called severe aortic stenosis. In this condition, one of the main valves in your heart, the aortic valve, becomes hardened and can't open properly. This makes it harder for your heart to pump blood around your body, leading to symptoms like breathlessness, chest pain, or feeling very tired.

The NAVITOR valve is put into your heart using a procedure called Transcatheter Aortic Valve Replacement (TAVR). This is a less invasive way to replace the valve compared to traditional open-heart surgery. Instead of opening up your chest, doctors guide the new valve through a blood vessel, usually in your leg, up to your heart. The main goal of this study is to check how safe and how well this new NAVITOR valve works to improve the health of people with this condition.

The study will include patients who are judged by their medical team to be at a low or moderate risk for open-heart surgery. This means their doctors believe it would be reasonably safe for them to have surgery, but TAVR might still be a good option. The study is also looking at how well the NAVITOR valve works for people who already have a replacement valve that needs to be replaced again (called a "valve-in-valve" procedure).

Key takeaways

This study is testing a new heart valve called NAVITOR for severe aortic stenosis.
The valve is put in using a less invasive procedure called TAVR.
It's for people with severe symptoms and a low to medium surgical risk.
The study also looks at replacing an existing artificial valve.
Participation involves ongoing monitoring of your heart and the new valve.

Who may be eligible?

To be part of this study, your heart specialist team, including a heart surgeon, must agree that a procedure to replace your heart valve without open surgery is a good option for you. They will also need to think that your risk of complications from traditional open-heart surgery is low or moderate.

You would need to be experiencing symptoms from your heart condition, such as shortness of breath, tiredness, or chest discomfort. Special heart scans, like an echocardiogram (an ultrasound of your heart), must show that your aortic valve is severely narrowed.

There are also some reasons why you might not be able to join. For example, if your doctor believes your life expectancy is less than two years, or if you've recently had a heart attack. If you need other heart procedures within a short time frame, or have certain blood conditions, you also might not be eligible. They will also check the size of your heart's anatomy using scans to make sure the valve will fit correctly.

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.

Has my heart team, including a heart surgeon, agreed that a valve procedure without open surgery (TAVR) is appropriate for me?
Do I have symptoms from my aortic stenosis, like breathlessness or tiredness?
Do heart scans show that my aortic valve is severely narrowed?
Has it been more than 30 days since any recent heart attack or major heart procedure?
Do I believe my life expectancy is likely more than two years?
Do I meet the specific heart measurements (valve opening size, etc.) that the doctors will check with scans?

Answer every question to see your result.

What does participation involve?

The study does not specify the exact details of participation. However, if you join, you would likely have regular visits to the hospital for check-ups and tests. These tests could include heart scans (like echocardiograms or CT scans) to monitor your new valve and your heart health. You would also have blood tests and physical examinations to see how you are feeling and if your symptoms have improved. You would be carefully followed by the study team for a period of time, which can vary depending on the trial, to track how well the NAVITOR valve is working and to ensure your safety. The total duration of your participation would be explained to you in detail.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new heart valve that could improve your heart function and reduce your symptoms without undergoing open-heart surgery. However, as with any medical procedure, there are potential risks, including side effects from the TAVR procedure or issues with the new valve itself. The study team will explain all known risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (37)

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

Fiona Stanley Hospital
Verified postcode
Murdoch, Australia
Prince of Wales Hospital
Verified postcode
Sydney, Australia
Princess Alexandra Hospital
Verified postcode
Woolloongabba, Australia
St. Andrew's Hospital
Verified postcode
Adelaide, Australia
The Alfred Hospital
Verified postcode
Melbourne, Australia
Macquirie University Hopsital
Verified postcode
Ryde, Australia
Kepler Universitätsklinikum GmbH
Verified postcode
Linz, Austria
AKH Wien
Verified postcode
Vienna, Austria
Rigshospitalet
Verified postcode
Copenhagen, Denmark
CHU Gabriel Montpied
Verified postcode
Clermont-Ferrand, France
Hopital Haut Leveque
Verified postcode
Pessac, France
Clinique Pasteur Toulouse
Verified postcode
Toulouse, France

Common questions

What is aortic stenosis?

Aortic stenosis is a heart condition where one of your heart's main valves, the aortic valve, becomes stiff and doesn't open wide enough, making it hard for blood to flow out of your heart.

What is TAVR?

TAVR stands for Transcatheter Aortic Valve Replacement. It's a way to replace your aortic valve using a thin tube inserted into a blood vessel, usually in your leg, without needing open-heart surgery.

Who is the NAVITOR valve for?

The NAVITOR valve is for people with severe aortic stenosis. This study is testing it specifically in patients who are considered to have a low to medium risk for traditional open-heart surgery.

Will this study cure my heart condition?

This study aims to evaluate if the NAVITOR valve can effectively treat severe aortic stenosis by replacing the faulty valve, which could significantly improve your symptoms and heart health.

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, and your decision will not affect the medical care you receive.