RecruitingNAINTERVENTIONAL

TARGET 2.0 Study: Safety and Performance of the Cardiovalve TR Replacement System

The TARGET 2.0 study is looking at a new heart device called the Cardiovalve TR Replacement System. This device is designed to treat a condition called tricuspid regurgitation (TR), where the heart's tricuspid valve doesn't close properly, letting blood leak backward. This can make people feel very unwell. The study will continue to check how well the Cardiovalve works and if it's safe for patients. It's for people who have severe TR and can't have open-heart surgery. The new valve is put in through a vein in the leg, avoiding major surgery. The information gathered from this study will help decide if the Cardiovalve can be made more widely available.

At a glance

Status

Recruiting

Phase

Sponsor

Cardiovalve Ltd.

Enrolment target

150

Start

20 Jan 2026

Estimated completion

01 Sep 2033

Tricuspid Regurgitation

What is this study about?

This study, called TARGET 2.0, is about a new way to treat a heart condition known as tricuspid regurgitation (TR). Your heart has four valves that act like one-way doors, making sure blood flows in the right direction. The tricuspid valve is one of these, located on the right side of your heart. In TR, this valve doesn't close properly, causing blood to leak backward. This can make you feel tired, short of breath, and your legs might swell.

The Cardiovalve TR Replacement System is a new device designed to fix this problem. It's a replacement valve, made from animal tissue and a special metal frame, which is delivered to your heart through a small tube (catheter) inserted in a vein in your leg. This means you wouldn't need open-heart surgery, which can be a big advantage for many people. The valve is carefully expanded and fixed in place once it reaches your heart.

This study is a follow-up to an earlier study. Its main goal is to carefully check that the Cardiovalve system is both safe to use and effective at reducing the blood leakage caused by TR. The information collected will be crucial for the company to get approval to make this device available to more patients. By taking part, you would be helping doctors understand if this new treatment can offer a better quality of life for people with severe tricuspid regurgitation.

Key takeaways

This study is for a new device to treat a heart valve problem called tricuspid regurgitation.
The Cardiovalve is put in through a vein in your leg, avoiding open-heart surgery.
It's for people with severe symptoms who can't have traditional surgery.
The study aims to confirm the device's safety and how well it works.
Your participation helps gather important information for future patients.

Who may be eligible?

To be considered for this study, you generally need to be between 18 and 85 years old and have severe tricuspid regurgitation that's causing noticeable symptoms, like breathlessness or swelling. Your doctors would have already tried other medical treatments, and you would be considered too risky for traditional open-heart surgery.

There are also specific measurements of your heart and blood vessels that need to be suitable for the Cardiovalve device to be put in safely. For instance, the vein in your leg needs to be wide enough, and certain parts of your heart cannot be too big or too small. You should also be in generally stable health, without other serious heart conditions or illnesses that might significantly shorten your life expectancy.

However, you wouldn't be able to participate if your heart or blood vessels aren't suitable for the device, or if you have certain other serious health issues like recent strokes, active infections in your heart, or severe problems with other heart valves that also need 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 between 18 and 85 years old?
Do you have severe tricuspid regurgitation with symptoms?
Has your doctor said you're too high-risk for open-heart surgery?
Are you currently on medical treatment for your heart condition?
Do you have a general understanding of what the study involves?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a thorough check-up to make sure you meet all the requirements. If eligible, the Cardiovalve device would be carefully placed in your heart. This procedure involves inserting a thin tube (catheter) into a vein in your leg.

After the procedure, doctors would closely monitor your recovery in the hospital. You would then have regular follow-up appointments, which may include tests like ultrasounds of your heart (echocardiograms) and other scans, to check how well the new valve is working and your overall health. These appointments would likely happen at set times over a period, potentially for several years, to track your progress long-term. You would continue to take any necessary medications recommended by your doctors. Your research team will explain the exact schedule of visits and tests.

Potential risks and benefits

Taking part in a study like this could offer an potential benefit of improving your tricuspid regurgitation and relieving your symptoms without needing open-heart surgery. However, as with any medical procedure, there are potential risks, including discomfort during the procedure, bleeding, infection, and potential complications related to placing the new valve. Some risks might be serious, and the Cardiovalve system itself is still being studied, so its long-term effects are not fully known. You would be fully informed of all known and potential risks before deciding to participate. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Uniklinik Bonn -
Verified postcode
Bonn, Germany· Recruiting

Common questions

What is tricuspid regurgitation?

It's a condition where the tricuspid valve in your heart doesn't close properly, causing blood to leak backwards. This can make you feel tired and short of breath.

How is the Cardiovalve put into my heart?

The new valve is inserted using a thin tube (catheter) through a vein, usually in your leg. This avoids the need for major open-heart surgery.

Why is this study called TARGET 2.0?

This study is a continuation of an earlier study called TARGET. It aims to gather more information on the Cardiovalve's safety and effectiveness.

Will I still need to take my usual medications?

Yes, unless your doctor advises otherwise, you would continue with your prescribed medical therapy as part of your care.

What is the main goal of this study?

The main goal is to show that the Cardiovalve system is safe and works well for people with severe tricuspid regurgitation, to help it become more widely available.

How to find out more

Dana Raveh Arbel

danar@cardiovalve.com 0528591891 Official trial record

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