Active not recruitingNAINTERVENTIONAL

Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease

This study is looking at a new type of heart valve, called TRICENTO, to help people who have a condition called carcinoid heart disease. This condition can cause a heart problem where one of the valves, the tricuspid valve, doesn't close properly, leading to what doctors call tricuspid regurgitation. For those who can't have traditional open-heart surgery to fix this valve, this new TRICENTO device is implanted using a less invasive procedure. The study hopes to find out if this device helps reduce the leaking in the tricuspid valve, makes people feel better, and improves their day-to-day life. It will involve 15 people.

At a glance

Status

Active not recruiting

Phase

Sponsor

Queen Mary University of London

Enrolment target

Start

06 Apr 2022

Estimated completion

21 May 2028

Tricuspid Regurgitation Tricuspid Valve Disease Carcinoid Syndrome Carcinoid Heart Disease

What is this study about?

This study is investigating a new treatment for a specific heart problem called tricuspid regurgitation, which can happen to people with carcinoid heart disease. Carcinoid heart disease is a complication that can arise from carcinoid syndrome, a type of cancer. In this heart condition, the tricuspid valve, which controls blood flow on the right side of your heart, can become damaged and leak. This leaking makes your heart work harder and can cause symptoms like tiredness and shortness of breath. Often, surgery is an option to replace or repair this valve.

However, for some people, surgery might not be possible – perhaps due to the ongoing cancer treatment or other health reasons. This new treatment, called the TRICENTO Valved Stent Graft, is designed to be put in place without major open-heart surgery. It's a new valve that's delivered through a small tube (a catheter) into your heart, a procedure often called 'transcatheter'.

The main goal of this study is to see if the TRICENTO valve can reduce the leaking in the tricuspid valve, improve the symptoms people experience, and ultimately make their quality of life better. Researchers will carefully check how well the new valve works and if it helps people feel healthier.

Key takeaways

Tests a new 'TRICENTO' heart valve for specific heart problems.
Aims to help people with carcinoid heart disease who can't have surgery.
Valve implanted using a less invasive procedure, not open-heart surgery.
Study will measure symptom improvement and quality of life.
Involves hospital stay and follow-up visits over 6 months.
Participation is voluntary and you can leave at any time.

Who may be eligible?

This study is looking for people aged 18 or over who have carcinoid heart disease and severe leaking of their tricuspid valve. You need to be experiencing noticeable symptoms from this heart condition, making everyday life harder. Crucially, you must not be able to have usual heart surgery to fix your valve, either because of your cancer treatment or because you've decided against it. You also need to be able to understand and follow the study instructions, and be able to complete questionnaires in English.

You would not be able to join if you've already had surgery or other procedures on your tricuspid valve, or if you have certain other serious health issues like severe, uncontrolled high blood pressure, active heart infection, or severe problems with your blood clotting. Pregnancy or breastfeeding also means you can't take part. There are other medical reasons that might prevent you from joining, such as having certain metal allergies or other recent heart problems.

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 carcinoid heart disease with severe leaking of your tricuspid heart valve?
Are you experiencing symptoms from this heart condition?
Have doctors told you that you cannot have open-heart surgery for your heart valve, or have you decided against it?
Are you able to speak and understand English to complete questionnaires?
Have you *not* had any previous surgery or procedure on your tricuspid heart valve?

Answer every question to see your result.

What does participation involve?

If you're interested in taking part, the first step is to have a conversation with the study team. They will explain everything in detail, including any potential risks and benefits, and make sure you understand what's involved. If you decide to go ahead, you'll sign a consent form. Then, you'll have some checks to see if the study is right for you. These will include looking at your medical history and having scans like a CT scan and an echocardiogram (an ultrasound of your heart).

If you're suitable, a custom TRICENTO valve will be made for you. You'll then need to stay in hospital for the valve to be put in. Before the procedure, you'll have more checks, including an ECG (heart tracing), a heart MRI scan, blood tests, and some questionnaires. They'll also measure things like your height, weight, blood pressure, and how far you can walk in 6 minutes. The valve is put in during a procedure that usually takes about 30-60 minutes. You'll likely be able to go home 2-3 days later after getting a recovery check, another echocardiogram, and further blood tests and questionnaires.

After you go home, you'll have follow-up visits after 1 month and again after 6 months. At these visits, many of the same tests will be repeated – including an ECG, echocardiogram, physical measurements, blood tests, questionnaires, and the 6-minute walk test. You'll also have another heart MRI scan at the 6-month visit. All these tests help the doctors understand how well the TRICENTO valve is working for you and if it's improving your heart health and quality of life. The total duration of active participation and follow-up for this study will be 6 months after your procedure.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The potential benefits for you in this study could include an improvement in your heart condition symptoms and a better quality of life if the TRICENTO valve works well. However, this is a new device and, like any medical procedure, there are potential risks, such as those related to the procedure itself, the device, or the medications used. The study team will explain these in detail. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Barts Health NHS Trust
Verified postcode
London, United Kingdom

Common questions

What is carcinoid heart disease?

It's a heart problem that can develop in some people with carcinoid syndrome (a type of cancer). It often affects the heart valves, making them not work as well as they should.

What does 'transcatheter' mean?

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

Will I need to stay in hospital after the procedure?

Yes, you would typically need to stay in hospital for about 2-3 days after the new valve is put in, for recovery and some follow-up checks.

How many times will I need to visit the hospital for this study?

After the initial screening, you'll have a hospital stay for the procedure, followed by two more visits for checks at 1 month and 6 months after your procedure.

Can I still have the procedure if I'm able to have surgery?

No, this study is specifically for people with carcinoid heart disease who are not able to have traditional heart surgery to fix their valve problem.