RecruitingNAINTERVENTIONAL

HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

This study, called HighFLO, is investigating a new type of heart valve called CLARITY. It's designed for people who have a condition called mitral regurgitation, which means a valve in their heart leaks. This leakage can make you feel tired and out of breath. The goal of the study is to check if this newCLARITY valve, and the way it's put into the heart, is safe and works effectively. It's particularly focused on patients who are considered too sick or too high-risk for traditional open-heart surgery. Researchers want to understand if this new treatment option could help improve their quality of life. The study will look at how well patients recover and how the new valve performs over time.

At a glance

Status

Recruiting

Phase

Sponsor

HighLife SAS

Enrolment target

Start

01 Jul 2021

Estimated completion

01 Feb 2031

Mitral Regurgitation

What is this study about?

This study is called HighFLO and it's looking into a new way to treat a common heart problem. Your heart has four valves, and they're like doors that open and close to keep your blood flowing in the right direction. One of these is called the mitral valve. If this valve doesn't close properly, blood can leak backwards, a condition known as mitral regurgitation. This can make your heart work harder and lead to symptoms like breathlessness, tiredness, and swelling.

For many people with a leaky mitral valve, surgery is an option to fix or replace it. However, some people are too frail or have other health problems that make open-heart surgery too risky. This study is testing a new device called the HighLife CLARITY valve. Instead of major open-heart surgery, this new valve is put into your heart using a less invasive method, often through a blood vessel, which means it might be an option for those who can't have traditional surgery.

The main goal of the HighFLO study is to see if this new CLARITY valve and the tools used to put it in are safe and work well. They want to understand if it can help reduce the symptoms of a leaky mitral valve in people who are considered high risk for surgery. It's an important step in finding new and safer ways to help people with this heart condition.

Key takeaways

This study tests a new valve (CLARITY) for leaky hearts.
It's for people too high-risk for open-heart surgery.
The valve is placed using a less invasive method.
The study checks if the valve is safe and works well.
You'll have regular check-ups if you join.
Participation is voluntary, and you can leave anytime.

Who may be eligible?

To be considered for this study, you would generally need to be at least 18 years old and have a moderate-to-severe or severe leaky mitral valve. You should also be experiencing significant symptoms like breathlessness or tiredness, even after trying standard medications for at least a month. A team of heart specialists must also agree that traditional open-heart surgery would be too risky for you, and that you meet the specific heart measurements required for this new valve.

There are also some reasons why you might not be able to join. For example, if you've recently had a stroke, have a severe infection, or uncontrolled bleeding issues, you likely wouldn't be eligible. The study also cannot include pregnant or breastfeeding individuals, or those who can't attend follow-up appointments. If you're currently in another medical trial, have severe allergies to the device materials, or can't take blood-thinning medication, you also wouldn't be able to participate. Your doctors will carefully check all these points to see if the study is right for you.

Quick self-check

Are you at least 18 years old?
Do you have a moderate-to-severe or severe leaky heart valve?
Are you experiencing significant symptoms like shortness of breath or tiredness?
Has your heart team said traditional open-heart surgery is too risky for you?
Can you attend regular follow-up appointments?
Are you able to take blood-thinning medication if needed?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive the new CLARITY heart valve. This involves a procedure to implant the valve, which is less invasive than open-heart surgery. After the procedure, you'll have regular check-ups with the study team. These check-ups will involve various tests and appointments to see how you're recovering, how the new valve is working, and if your symptoms have improved. You’ll need to make sure you can attend all these scheduled visits. The total length of your participation, including all follow-up appointments, will be explained to you by the study team.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new treatment that might improve your heart condition and symptoms, especially if traditional surgery isn't an option for you. However, as with any medical procedure, there are potential risks, including those related to the implantation procedure and how your body reacts to the new device. The study team will explain all known risks to you in detail. Remember, choosing to participate is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

Wesley Hospital
Auchenflower, Australia· Recruiting
Mount Hospital
Perth, Australia· Recruiting
Macquarie University Hospital
Sydney, Australia· Terminated
AZ St. Jan - Brugge
Bruges, Belgium· Recruiting
UZ Leuven
Leuven, Belgium· Recruiting
CHU Lille
Lille, France· Recruiting
Centre Hospitalo - Univ de Nantes
Nantes, France· Recruiting
CHU de Rennes
Rennes, France· Recruiting
Cliniue Pasteur
Toulouse, France· Recruiting
Deutsches Herzzentrum Munchen
Munich, Germany· Recruiting
University Hospital Ulm
Ulm, Germany· Recruiting
Medical University of Silesia
Katowice, Poland· Recruiting

+2 more sites — see the official record for the full list.

Common questions

What is mitral regurgitation?

It's a condition where a valve in your heart, called the mitral valve, doesn't close properly, causing blood to leak backwards. This can make your heart work harder.

What is the CLARITY valve?

The CLARITY valve is a new artificial heart valve being tested. It's designed to be put into your heart using a less invasive method than traditional open-heart surgery.

Who is this study for?

It's for adults with a significant leaky mitral valve whose health makes traditional open-heart surgery too risky.

Will I have to have surgery?

The CLARITY valve is implanted through a less invasive procedure, not traditional open-heart surgery, because the study is designed for those who can't have open heart surgery.

Can I leave the study at any time?

Yes, your participation is voluntary, and you can withdraw from the study at any point without it affecting your medical care.

How to find out more

Luc Verhees

lverhees@highlifemed.com +31 6 4270 2457 Official trial record

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