Not yet recruitingOBSERVATIONAL

TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease

The TAVIS Registry is collecting important information about a procedure called Transcatheter Aortic Valve Implantation (TAVI), which uses the Trilogy Heart Valve System. This treatment is for people whose aortic heart valve isn't working properly – either it's too narrow (aortic stenosis) or it's leaky (aortic regurgitation). These conditions can make you feel tired and short of breath. TAVI is a less invasive way to replace the faulty valve. This study aims to gather real-world data from patients who receive this treatment, helping doctors understand its effectiveness and how patients recover. It's for adults aged 18 and over who have been advised by their doctor to have this procedure.

At a glance

Status

Not yet recruiting

Sponsor

JenaValve Technology, Inc.

Enrolment target

600

Start

01 Mar 2023

Estimated completion

01 Oct 2027

Aortic Valve Stenosis Aortic Valve Regurgitation Aortic Valve Stenosis With Insufficiency Constriction, Pathologic Aortic Valve Disease Heart Valve Diseases Cardiovascular Diseases in Old Age Ventricular Outflow Obstruction Aortic Stenosis, Severe

What is this study about?

Your heart has four valves that act like one-way doors, making sure blood flows in the right direction. The aortic valve is particularly important as it controls blood flow from your heart to your body. Sometimes, this valve can become faulty. If it gets too narrow (called aortic stenosis), it's harder for blood to leave your heart. If it becomes leaky (aortic regurgitation), blood flows backward into your heart. Both of these problems can make you feel tired and short of breath, and can affect people of all ages, though they are more common in older adults.

Traditionally, these problems might be fixed with open-heart surgery. However, new techniques like Transcatheter Aortic Valve Implantation (TAVI) offer a less invasive option. Instead of opening the chest, a new valve is carefully guided through a blood vessel, usually in the leg, and placed into the heart where it replaces the old, faulty valve. This study, called the TAVIS Registry, is specifically looking at a new TAVI system called the Trilogy Heart Valve System.

The main goal of this study is to understand how well the Trilogy Heart Valve System works for people with severe aortic valve problems. Doctors will collect information on patients who have this procedure to see how their symptoms improve and how they get on after the treatment. This will help them learn more about who might benefit most from this innovative procedure and ensure it's used safely and effectively across the UK.

Key takeaways

It's a study for people with severe aortic valve problems (narrowing or leaking).
It uses a less invasive procedure called TAVI with the Trilogy Heart Valve System.
The study collects information on how well this treatment works in real-world patients.
You must be 18 or over and recommended for this treatment by your heart team.
Participation involves your standard treatment and attending follow-up appointments.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To join this study, you would need to be 18 years old or older and have a serious problem with your aortic heart valve, either it's too narrow (severe aortic stenosis) or it's leaky (severe aortic regurgitation). Importantly, your heart specialist team would need to recommend the Trilogy Heart Valve System as the best treatment for you, and agree that you could have traditional open-heart surgery as a backup if needed during the procedure.

You also need to be willing to sign a consent form, which means you understand the study and agree to share your health information. You must also commit to attending all required follow-up appointments after your procedure. This helps doctors track your progress and collect all the necessary information for the study.

There are also some reasons why you might not be able to join. For instance, if you are allergic to certain materials in the valve or contrast dyes used in medical scans, or if you have specific heart conditions like a current infection in your heart or a blood clot. You also can't participate if you've already had a different artificial aortic valve put in, or if you are pregnant or breastfeeding.

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.

Are you 18 years old or older?
Has your heart specialist team recommended you for the Trilogy TAVI procedure?
Do you have severe aortic valve narrowing (stenosis) or a leaky aortic valve (regurgitation)?
Are you willing to attend all follow-up appointments after your procedure?
Do you have any severe allergies to metals like nickel or titanium, or to x-ray dyes?
Are you currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement would primarily revolve around your standard treatment with the Trilogy Heart Valve System. This means you would have the TAVI procedure as recommended by your heart specialist team. The study then involves collecting information about your health and recovery journey. You will need to attend all of your planned follow-up appointments after the procedure, just as you would normally, and those visits will be used to collect the study data. These appointments typically involve checks to see how you are recovering and how well the new valve is working. The exact number and timing of visits will be discussed with you by your medical team, but it's important that you commit to attending them to help the study gather complete information. There is no special medication you would take for the study itself, but you would continue with any medications prescribed by your doctor as part of your normal care.

Potential risks and benefits

Participating in this study means you would receive treatment for your aortic valve disease, which could lead to an improvement in your symptoms like tiredness and shortness of breath, and a better quality of life. As with any medical procedure, there are potential risks associated with the TAVI procedure itself, which your doctor will explain in detail. These can include complications from the procedure or from the devices used. The main benefit of participating is that your medical team will closely monitor your health and the performance of your new heart valve. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (3)

Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
Verified postcode
Bad Oeynhausen, Germany
University Hospital of Cologne Heart Center
Verified postcode
Cologne, Germany
University Hospital Mainz
Verified postcode
Mainz, Germany

Common questions

What is the Trilogy Heart Valve System?

It's a specific type of replacement heart valve used in a less invasive procedure called TAVI to fix problems with your aortic valve.

What's the difference between aortic stenosis and aortic regurgitation?

Aortic stenosis means your aortic valve is too narrow, making it hard for blood to leave your heart. Aortic regurgitation means your aortic valve leaks, allowing blood to flow backward.

Is TAVI surgery?

TAVI is a procedure to replace your aortic valve that is less invasive than traditional open-heart surgery. It's done by guiding a new valve through a blood vessel.

Will I have to pay to be in the study?

No, you don't pay to be in the study. Your treatment would be provided as part of the standard medical care, and the study involves collecting data from that care.

What if I change my mind about participating?

You can decide to stop participating in the study at any time, and this will not affect the quality of your medical care.

How to find out more

Vinny Podichetty, Vice President: Clinical & Med Affairs

podichetty@jenavalve.com 949-767-2110 Official trial record

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