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Enrolling by invitationNAINTERVENTIONAL

ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation

The ENVISION study is testing a new way to replace a heart valve, called the Navitor TAVI system. This treatment is for people whose main heart valve (the aortic valve) has become stiff and narrow, making it hard for blood to flow properly. This condition is called severe aortic stenosis. The study is checking if the Navitor system is safe and works well, both for people having a valve replacement for the first time and for those needing a replacement for an old, failing valve. It also looks at people with a specific valve shape called a bicuspid aortic valve. The aim is to find out if this new valve system is a good option for people with this serious heart condition.

At a glance

Status
Enrolling by invitation
Phase
NA
Sponsor
Abbott Medical Devices
Enrolment target
1,500
Start
15 Mar 2024
Estimated completion
01 Apr 2036
Aortic Valve StenosisHeart Valve DiseasesAortic Valve DiseaseHeart Disease Structural Disorder

What is this study about?

This study, called ENVISION, is looking at a new type of heart valve replacement called the Navitor Transcatheter Aortic Valve Implantation (TAVI) system. When you have severe aortic stenosis, it means the main valve in your heart (the aortic valve) has become stiff and narrow. This makes your heart work much harder to pump blood around your body, which can cause symptoms like breathlessness, chest pain, or feeling faint. Replacing this faulty valve can greatly improve these symptoms and your overall health.

The TAVI procedure is a less invasive way to replace the valve, meaning it doesn't always require open-heart surgery. Instead, the new valve is guided into place through a small cut, usually in the leg. This study wants to find out if the Navitor TAVI system is a safe and effective choice for people with severe aortic stenosis. It's looking at different groups of patients: those who haven't had a valve replacement before and are considered to have a low or medium risk for traditional surgery; those who already have an artificial valve that's stopped working properly; and those with a specific valve shape called a bicuspid aortic valve.

By carefully comparing the Navitor system to other available treatments, researchers hope to understand if it offers a good and safe solution for a wide range of people suffering from this serious heart condition. The results of this study will help doctors decide the best treatment options for their patients in the future.

Key takeaways

  • Tests a new less-invasive heart valve replacement system called Navitor TAVI.
  • Aims to improve symptoms for people with a narrowed heart valve (severe aortic stenosis).
  • Compares Navitor to other existing TAVI treatments in some parts of the study.
  • Includes people needing a first-time valve replacement and those with a failing old valve.
  • Involves regular check-ups for up to five years after the procedure.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have severe narrowing of their aortic heart valve. You might be considered if you have symptoms like feeling breathless, tired, or having chest pain, and your heart condition is affecting your daily life. Doctors will also consider your overall health and if you are at a low or medium risk for traditional open-heart surgery.

There are also special groups being looked at. One group is for people who have an artificial heart valve (either from previous surgery or another TAVI) that is no longer working well and needs to be replaced. Another group is for those with a specific valve shape called a 'bicuspid aortic valve' who also have severe narrowing.

However, there are reasons why you might not be able to join. For example, if your doctor believes you have less than two years to live due to other serious health issues, or if you've recently had a heart attack, stroke, or severe kidney problems. Also, if you have certain blood disorders or active stomach ulcers, or if you've recently had other heart procedures, you might not be suitable. The medical team will carefully check all these details to see if this study is right for you.

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.

  1. Are you an adult aged 18 or older?
  2. Have you been diagnosed with severe narrowing of your aortic heart valve?
  3. Do you experience symptoms like breathlessness, chest pain, or fainting due to your heart condition?
  4. Are you considered by your doctor to be at low or medium risk for traditional heart surgery?
  5. Have you *not* had a heart attack or stroke in the last six months?
  6. Do you *not* have severe kidney disease requiring dialysis?
Answer every question to see your result.

What does participation involve?

If you join this study, you would be receiving the Navitor TAVI system or another approved TAVI system to treat your heart valve problem. After your valve replacement procedure, the study team would regularly check on your health. This involves clinic visits, typically at 1 month, 6 months, and then yearly for up to five years. During these visits, you might have examinations, blood tests, and heart scans (like echocardiograms) to see how your new valve is working and how you are feeling. You would also be asked about your symptoms and quality of life. The total duration of follow-up for the study could be up to five years.

Potential risks and benefits

Participating in a clinical study means you could be among the first to benefit from a new treatment like the Navitor TAVI system if it proves to be effective. The new valve could significantly improve your heart function and reduce your symptoms, potentially leading to a better quality of life. However, as with any medical procedure, there are potential risks, such as those associated with TAVI procedures in general (like bleeding, infection, or issues with the new valve). You will be closely monitored, and your care team will explain all known risks. Remember, taking part in a study is always voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (107)

  • University Hospital - Univ. of Alabama at Birmingham (UAB)
    Verified postcode
    Birmingham, United States
  • St. Joseph's Hospital & Medical Center
    Verified postcode
    Phoenix, United States
  • Tucson Medical Center
    Verified postcode
    Tucson, United States
  • Arkansas Heart Hospital
    Verified postcode
    Little Rock, United States
  • Kaiser Permanente Fontana Medical Center
    Verified postcode
    Fontana, United States
  • Southern California Permanente Medical Group - La Jolla
    Verified postcode
    La Jolla, United States
  • University of California at San Francisco
    Verified postcode
    San Francisco, United States
  • Stanford University Medical Center
    Verified postcode
    Stanford, United States
  • Los Robles Regional Medical Center
    Verified postcode
    Thousand Oaks, United States
  • St. Joseph's Hospital & Medical Center
    Verified postcode
    Denver, United States
  • Washington Hospital Center
    Verified postcode
    Washington D.C., United States
  • HCA Florida - JFK Hospital
    Verified postcode
    Atlantis, United States

Common questions

What is 'aortic stenosis'?

It's a common heart problem where the main valve in your heart (the aortic valve) becomes stiff and narrow, making it harder for blood to pump out of your heart.

What is TAVI?

TAVI stands for Transcatheter Aortic Valve Implantation. It's a less invasive procedure to replace a faulty aortic valve, often done through a small cut, usually in the leg, instead of open-heart surgery.

What is a 'bicuspid aortic valve'?

Normally, the aortic valve has three small flaps. A bicuspid valve means it only has two flaps, which can sometimes lead to problems like narrowing earlier in life.

Will I get the new Navitor valve?

In the main part of the study, some people will get the Navitor valve, and others will get another approved valve, decided randomly. In other parts of the study, everyone receives the Navitor valve.

How long will I be in the study?

You'll have follow-up appointments and checks for up to five years after your valve replacement procedure to see how you're doing.

How to find out more

Official trial record

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

Interested in taking part?

Register your interest

Share your details and the research team for "ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in T…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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