RecruitingNAINTERVENTIONAL

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation

This clinical study is looking into a new way to treat a leaky heart valve, specifically the tricuspid valve, which is located on the right side of your heart. When this valve doesn't close properly, it's called tricuspid regurgitation. The new treatment involves using a device called the VDyne Transcatheter Tricuspid Valve Replacement System. This system is designed to replace the faulty valve without needing open-heart surgery. The main goal of this study is to gather information on how safe and effective this new VDyne system is. The results will help decide if it can get a special approval mark (CE Mark) so that more people who need it can benefit from this treatment in the future. It's for adults 18 and over with severe leakage and specific heart conditions.

At a glance

Status

Recruiting

Phase

Sponsor

VDyne, Inc.

Enrolment target

120

Start

01 Mar 2023

Estimated completion

30 Dec 2030

Tricuspid Regurgitation Tricuspid Valve Disease Tricuspid Valvular Disorders

What is this study about?

You might be reading this because you or someone you care about has been told they have a problem with their tricuspid valve, which is one of the four essential valves in your heart. This valve's job is to control blood flow from the right upper chamber to the right lower chamber of your heart. When it doesn't close properly, blood can leak backwards, a condition known as tricuspid regurgitation. This can make your heart work harder and lead to symptoms like tiredness, shortness of breath, and swelling.

Traditionally, major surgery might have been the main option to fix a severely leaky tricuspid valve. However, medical science is always looking for less invasive ways to help patients. This particular study is evaluating a new approach called the VDyne Transcatheter Tricuspid Valve Replacement System. 'Transcatheter' means the new valve can be put into place using a thin, flexible tube (catheter) threaded through your blood vessels, usually from your leg, rather than requiring open-heart surgery.

The main purpose of this study is to carefully assess if the VDyne system is both safe to use and effective at treating the leaky valve. Researchers will be observing participants closely to understand how the new valve performs, if it improves their symptoms, and if there are any side effects. The information gathered from this study is crucial because it helps regulatory bodies decide if this new treatment should be approved and made available to more people across Europe. Think of it as a thorough testing process to ensure new medical devices meet high standards of care.

Key takeaways

This study is testing a new, less invasive way to fix a leaky tricuspid heart valve.
The treatment involves a device called the VDyne Transcatheter Tricuspid Valve Replacement System.
It aims to find out if the VDyne system is safe and works well for patients.
The results will help make this treatment more widely available if successful.
Participants must be 18 or older and have severe tricuspid valve leakage.
Close monitoring and follow-up are part of taking part in the study.

Who may be eligible?

To join this study, people generally need to be adults aged 18 or older and have a serious leak in their tricuspid heart valve (doctors call this 'severe or greater tricuspid regurgitation'). Their heart symptoms should also be significant enough to affect their daily life, even after trying standard medications, but they still need to be able to move around. A team of heart specialists will review each potential participant to make sure the VDyne system is a suitable treatment option for them, and that their heart and blood vessels are shaped in a way that allows the procedure to be done safely.

There are also some reasons why someone might not be able to join. For example, if their body would react badly to the materials used in the VDyne system (like nickel or titanium), or if they can't take the necessary blood-thinning medicines because of allergies or other issues. People with certain very specific heart conditions, like a very weak main pumping chamber (left ventricle) or severe problems with their right pumping chamber, might also not be eligible. Active infections of the heart or recent serious infections, severe blockages in other heart arteries that need urgent attention, or other planned surgeries soon before or after the valve replacement would also prevent participation, to ensure safety and focus on the VDyne treatment.

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?
Do you have a significant leak in your tricuspid heart valve?
Are your heart symptoms affecting your daily life despite taking medication?
Has a heart specialist team said this new treatment might be right for you?
Are you able to take blood-thinning medications or other necessary drugs for the procedure?
Do you have any severe heart conditions, like very weak main heart chambers or active infections, that would make this procedure unsafe?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part in this study, you will receive the VDyne Transcatheter Tricuspid Valve Replacement System as your treatment. This procedure involves inserting the new valve using a catheter, which usually means a stay in the hospital. After the procedure, there will be a schedule of follow-up visits to check on your progress, how well the new valve is working, and your general health. These visits will involve various tests and assessments, such as heart scans, blood tests, and discussions about your symptoms. You'll likely need to take specific medications, such as blood thinners, both shortly after the procedure and potentially long-term. The total duration of your participation in the study, including all follow-up appointments, will be clearly explained by the study team, but generally, clinical trials involve monitoring for several months to a few years to track long-term safety and effectiveness.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study is receiving a new, less invasive treatment for your leaky tricuspid valve that might improve your heart function and reduce your symptoms, potentially leading to a better quality of life. However, like any medical procedure, there are potential risks, including those associated with the procedure itself (such as bleeding, infection, or complications related to the device coming loose or not working as expected), and side effects from medications. The research team will explain all known and potential risks in detail, and your safety will be closely monitored throughout the study. Remember, participating in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (21)

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

St. Vincent Hospital
Verified postcode
Sydney, Australia· Recruiting
Flinders Medical Centre
Verified postcode
Adelaide, Australia· Recruiting
Princess Alexandra Hospital
Verified postcode
Brisbane, Australia· Recruiting
The Prince Charles Hospital
Verified postcode
Brisbane, Australia· Recruiting
Monash Heart
Verified postcode
Melbourne, Australia· Recruiting
Johannes Kepler University Linz - JKU
Verified postcode
Linz, Austria· Recruiting
Universitätsklinik für Herzchirurgie Medizinische Universität Wien
Verified postcode
Vienna, Austria· Recruiting
AZ Sint Jan Hospital
Verified postcode
Bruges, Belgium· Recruiting
Nemocnice AGEL Podlesi Trinec
Verified postcode
Třinec, Czechia· Recruiting
University Hospital of Copenhagen
Verified postcode
Copenhagen, Denmark· Recruiting
Herz & Diabeteszentrum Nordrhein Westfalen
Verified postcode
Bad Oeynhausen, Germany· Recruiting
Vivantes Klinik Am Urban
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is the tricuspid valve and why is it important?

The tricuspid valve is one of your heart's four valves. It controls blood flow from the upper right chamber to the lower right chamber. If it leaks, your heart has to work harder.

What does 'transcatheter' mean?

It means the new valve is put into your heart using a thin tube (catheter) inserted through a blood vessel, usually in your leg, rather than through open-heart surgery.

What is a 'CE Mark'?

The CE Mark is a special approval that shows products meet health, safety, and environmental protection standards for sale in Europe. This study aims to get that mark for the VDyne system.

Will I have to undergo surgery?

The VDyne system is implanted using a 'transcatheter' approach, which is less invasive than traditional open-heart surgery. It does involve a medical procedure, but not a large surgical cut to open the chest.

Can I leave the study if I change my mind?

Yes, taking part in a study is always voluntary. You can decide to leave at any time, and it won't affect any future medical care you receive.

How to find out more

Vinny Podichetty

vpodichetty@vdyne.com +1.763.777.5969 Official trial record

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