Not yet recruitingNAINTERVENTIONAL

TRicuspid Uk STudy

This study, called TRicuspid Uk STudy, is investigating a new treatment called TriClip for people with a heart problem called tricuspid regurgitation. This condition means the heart's tricuspid valve doesn't close properly, causing blood to leak backward. Researchers want to see if the TriClip device, which fixes the valve, improves how patients feel and their overall health compared to a dummy procedure (placebo). 150 patients will take part, with half getting the TriClip and half getting the dummy procedure. The study will last for three years and is happening at hospitals in London and Oxford.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Barts & The London NHS Trust

Enrolment target

150

Start

31 Jul 2026

Estimated completion

01 Dec 2028

Tricuspid Regurgitation

What is this study about?

Imagine your heart has several doors that control blood flow. One of these doors is called the tricuspid valve. In some people, this door doesn't close tightly, allowing blood to leak backward into the wrong chamber. This condition is called tricuspid regurgitation, and it can make people feel tired, short of breath, and generally unwell.

This study is testing a new way to fix this leaky valve without open-heart surgery. It uses a small clip, called TriClip, which is guided through a blood vessel to the heart to help the valve close better. The main goal of this study is to find out if using the TriClip device helps people with severe tricuspid regurgitation feel better and improve their quality of life, compared to having a dummy procedure that doesn't involve the clip.

The study will involve 150 patients. Half of these patients will receive the TriClip treatment, and the other half will have a dummy procedure. This is done so researchers can accurately compare the effects of the TriClip. The study will carefully measure how patients' health and well-being change over three years after their procedure.

Key takeaways

This study evaluates a new treatment for a leaky heart valve.
It compares the TriClip device with a dummy procedure.
The main goal is to see if TriClip improves how patients feel.
150 patients will participate over three years.
Participation involves monitoring and follow-up at specific hospitals.

Who may be eligible?

To join this study, you need to be over 18 years old and have been diagnosed with severe tricuspid regurgitation that is causing you symptoms. Your regular heart medications should have been stable for at least a month. Your heart doctor will also need to check that your tricuspid valve's shape and condition are suitable for the TriClip device to work effectively, meaning the clip should significantly reduce the leak in the valve.

There are also some reasons why you might not be able to join. For example, if you have other serious health problems that might make it unsafe, or if your life expectancy is less than a year. If you have a very weak heart (your doctor calls this a low left ventricular ejection fraction), or if the shape of your tricuspid valve isn't suitable for the TriClip, you wouldn't be able to participate. Also, certain other heart conditions or difficulties in seeing your heart clearly with scans might prevent you from joining.

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 over 18 years old?
Do you have severe tricuspid regurgitation with symptoms?
Have your heart medications been stable for at least one month?
Are your heart scans suitable for the TriClip device?
Do you have any other serious health conditions that might prevent you from joining?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you would first have a full assessment to ensure the study is right for you. If you are eligible, you would be randomly assigned to either receive the TriClip device or a dummy procedure. This means you wouldn't get to choose which group you are in. Both procedures involve going into your heart through a blood vessel, typically in your leg, while you are under anaesthetic.

After the procedure, you would have regular follow-up appointments over three years. These appointments would involve check-ups, scans of your heart, and answering questionnaires about how you are feeling and your quality of life. You'd continue to take your regular medications as prescribed throughout the study. The study aims to understand the long-term effects of the treatment.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. One potential benefit is that the TriClip procedure might improve your heart condition and make you feel better. However, as it’s a study, there's also a chance you might receive the dummy procedure or that the TriClip might not help you. There are always risks associated with any medical procedure, including bleeding, infection, or other complications, which your doctor will discuss fully. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

St Bartholomew's Hospital
Verified postcode
London, United Kingdom

Common questions

What is tricuspid regurgitation?

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

What is the TriClip device?

It's a small clip that helps your tricuspid valve close better, reducing the blood leak, and it's put in place without open-heart surgery.

What does 'placebo' mean in this study?

A placebo in this study means having a procedure that looks similar to the TriClip procedure but doesn't actually involve placing the clip.

How long will the study last?

The study will last for three years from when you join.

Where is this study taking place?

It's taking place at St Bartholomew's Hospital, John Radcliff Hospital, Royal Brompton Hospital, and Kings College London Hospital.

How to find out more

Kush Patel

kush.patel1@nhs.net +44 0207 3777 000 Official trial record

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