Active not recruitingOBSERVATIONAL

Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)

This study is investigating a new treatment for a common heart condition called tricuspid regurgitation. This is where one of the heart's valves, the tricuspid valve, doesn't close properly, causing blood to leak backward. The study aims to see how well and how safely a new device, called the Edwards Cardioband TR System, works to fix this problem. This device is fitted using a thin tube inserted into a blood vessel, avoiding open-heart surgery. Researchers want to understand if this system can improve symptoms and quality of life for patients. It's a 'post-market' study, meaning the device is already available, and this research helps gather more information about its real-world performance.

At a glance

Status

Active not recruiting

Sponsor

Edwards Lifesciences

Enrolment target

150

Start

24 Jul 2019

Estimated completion

31 Dec 2027

Tricuspid Regurgitation Tricuspid Insufficiency

What is this study about?

This study is about a heart problem called tricuspid regurgitation. Imagine your heart has four doors, called valves, that control how blood flows through it. One of these doors is the tricuspid valve. Sometimes, this door doesn't close tightly enough, causing blood to leak backward. This backward leak is called tricuspid regurgitation, and it can make your heart work harder and lead to symptoms like tiredness or swelling.

Doctors are exploring a new treatment called the Edwards Cardioband TR System to help fix this leaky valve. Instead of major open-heart surgery, this treatment uses a special device that's guided into your heart through a small tube in a blood vessel. Once in place, the device helps reshape the tricuspid valve so it can close more effectively, reducing the leak.

The main goal of this study is to carefully check how safe and effective this new treatment is for people with tricuspid regurgitation. By collecting information from many patients, doctors can better understand if this device is a good option for improving heart health and a patient's overall well-being.

Key takeaways

The study tests a new device for a leaky heart valve (tricuspid regurgitation).
It uses a minimally invasive procedure, not open-heart surgery.
The goal is to improve symptoms and heart function.
Eligibility depends on your specific heart condition and overall health.
Participation involves medical checks, the procedure, and follow-up appointments.
You can leave the study at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have been diagnosed with moderate or worse tricuspid regurgitation, where your tricuspid heart valve isn't working as it should. Your doctor will also need to confirm that your specific heart condition makes you a suitable candidate for the Edwards Cardioband TR System, based on its approved uses.

However, some things might prevent you from joining. For example, if detailed heart scans show that your heart's shape isn't suitable for the device, or if you've already had surgery on your tricuspid valve, you wouldn't be able to participate. Also, if you have other serious heart valve problems, severe kidney disease requiring dialysis, or a life expectancy of less than a year, you wouldn't be suitable.

Additionally, if you're pregnant or breastfeeding, or if you can't have a specific type of heart scan called a transesophageal echocardiogram (TEE), you wouldn't be able to join this study. The medical team will review all these factors carefully with 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.

Are you 18 years old or older?
Do you have moderate or worse tricuspid valve leakage?
Have you *not* had previous tricuspid valve surgery?
Are you *not* pregnant or breastfeeding?
Do you *not* have other severe heart valve problems or serious kidney disease?
Have doctors said your heart shape is suitable for this specific device?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the hospital. Initially, you'd undergo thorough medical checks, including detailed heart scans and other tests, to ensure the treatment is right for you. If you qualify and choose to proceed, you would have the Cardioband device implanted. This procedure is usually done without open-heart surgery, using a thin tube guided into your heart.

After the procedure, you'd have follow-up appointments where doctors will monitor your recovery, how the device is working, and your general health. These appointments will involve physical examinations, heart scans, and possibly blood tests. The medical team will explain the full schedule of visits and assessments you'd need to attend. The total duration of your participation, including follow-up, will be clearly outlined by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as improving how your tricuspid valve works, which could reduce your symptoms and improve your quality of life. However, like any medical procedure, there are potential risks, including those associated with placing the device or the anaesthesia. The medical team will explain all known risks in detail. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

Ulm University
Approximate
Ulm, Germany
Universitätsklinik der Ruhr-Universität Bochum
Verified postcode
Bad Oeynhausen, Germany
Herzzentrum der UniKlinik Köln
Verified postcode
Cologne, Germany
Charité - Universitätsmedizin Campus Mitte
Verified postcode
Berlin, Germany
Berlin Charité-Benjamin Franklin
Verified postcode
Berlin, Germany
Universitätsklinikum Bonn
Verified postcode
Bonn, Germany
Herzzentrum Universitätsklinik Dresden
Verified postcode
Dresden, Germany
University Hospital Erlangen
Verified postcode
Erlangen, Germany
Universitätsmedizin Göttingen, Herzzentrum Göttingen
Verified postcode
Göttingen, Germany
Asklepios Klinik St. Georg
Verified postcode
Hamburg, Germany
UKE Hamburg
Verified postcode
Hamburg, Germany
Katholisches Marienkrankenhaus
Verified postcode
Hamburg, Germany

Common questions

What is tricuspid regurgitation?

It's a heart condition where one of your heart's valves, the tricuspid valve, doesn't close properly, causing blood to leak backward into your heart.

What is the Edwards Cardioband TR System?

It's a special device designed to help reshape your leaky tricuspid valve so it can close more effectively and reduce the backward flow of blood.

Is this a surgery?

The procedure to implant the device is minimally invasive, meaning it's done using a thin tube inserted into a blood vessel, rather than traditional open-heart surgery.

What are the main reasons someone might not be able to join?

If your heart's shape isn't suitable for the device, you've had previous tricuspid valve surgery, or you have other severe heart or kidney conditions, you might not be eligible.

Will I have to pay to be in the study?

Clinical trials generally cover the costs related to the study intervention and specific study-related tests. You should discuss any potential personal costs with the study team.