RecruitingOBSERVATIONAL

Evaluation of the Elasticity of the Mitral Valve

This study aims to understand the elasticity (stretchiness) of tiny cords in the mitral valve of living people with mitral valve disease. Up until now, all the information we have comes from animal studies or frozen human tissue, which might not be entirely accurate for living hearts. Doctors are hoping to discover how these cords behave in real-time. They will compare two groups of patients: those with a condition called mitral valve prolapse and those with restrictive ischemic mitral valve disease. The goal is to collect detailed information about these tissues to better understand the conditions and eventually help doctors develop improved ways to treat problems with the mitral valve.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrolment target

Start

18 Oct 2021

Estimated completion

01 Mar 2025

Mitral Valve Disease

What is this study about?

Imagine your heart uses little doors, called valves, to control blood flow. One of these, the mitral valve, has tiny cords that help it open and close properly. Doctors don't currently have much information about how flexible or 'stretchy' these cords are in living people. All the knowledge we have actually comes from studies on animals or on human tissues that have been frozen after someone has passed away. This means that we don't fully understand how these vital cords work in a live, beating heart.

This study aims to change that. Doctors want to examine the real-life flexibility and structure of these mitral valve cords in people who are undergoing heart surgery for mitral valve problems. By doing this, they hope to get a much clearer picture of how these cords function. They will look at two main groups: people whose mitral valve sags or bulges (called mitral valve prolapse) and people whose valve stiffens due to blood flow problems (restrictive ischemic mitral valve).

Understanding these differences could be very important. If doctors know more about the actual properties of these cords, it could help them develop better surgical techniques, design improved treatments, or even create new valve repair materials in the future. Ultimately, this research is about improving care for people living with mitral valve conditions.

Key takeaways

This study focuses on understanding live heart valve tissue.
It aims to improve future treatments for mitral valve disease.
Participation involves no extra procedures beyond your planned surgery.
Samples are taken from tissue that would be removed anyway during your operation.
You must be having mitral valve replacement surgery and be at least 45.
Certain other heart conditions would prevent you from joining.

Who may be eligible?

To be considered for this study, you would need to be scheduled for an operation to replace your mitral valve and be at least 45 years old. This study specifically focuses on certain types of mitral valve issues.

There are also some reasons why you wouldn't be able to join. For example, if your mitral valve has hardened with calcium, or if your valve problems are caused by rheumatic fever or an infection, you wouldn't be eligible. Also, if you've had surgery on your mitral valve before, this study wouldn't be suitable for 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 scheduled for mitral valve replacement surgery?
Are you 45 years old or older?
Do you *not* have calcification (hardening) of your mitral valve?
Have you *not* had rheumatic heart disease affecting your mitral valve?
Do you *not* have an infection affecting your mitral valve?
Have you *not* had previous surgery on your mitral valve?

Answer every question to see your result.

What does participation involve?

If you are asked and agree to take part in this study, the main involvement for you would happen during your planned mitral valve replacement surgery. Doctors would collect small pieces of tissue from your mitral valve that would normally be removed during the operation anyway. This tissue would then be carefully studied in the lab right away, without being frozen, to keep it as close to its natural state as possible. There are no extra hospital visits or follow-up appointments specifically for this study beyond your standard surgical care. The study intervention itself takes place during your surgery, and its duration is limited to that time.

Potential risks and benefits

Participating in this study involves minimal risk to you, as the tissue samples collected are part of your routine surgery and would be removed anyway. There are no additional procedures or medications involved. For you personally, there's no direct medical benefit or change to your personal care from joining, but the information gained is incredibly valuable. It will help doctors better understand heart valve disease, which could lead to improved treatments for future patients. You are always free to decide if you want to take part, and you can change your mind at any point without it affecting your medical care.

Locations (1)

CHU Saint-Etienne
Verified postcode
Saint-Etienne, France· Recruiting

Common questions

What is the mitral valve?

The mitral valve is one of your heart's four main valves. It acts like a one-way door, controlling blood flow between two chambers on the left side of your heart.

Why are doctors studying this?

Doctors want to understand how flexible the tiny cords in the mitral valve are in living people. This information is currently missing and could help improve treatments for valve problems.

Will this study change my surgery?

No, participating in this study will not change your planned mitral valve replacement surgery or how it's performed.

Do I get any direct benefit?

There's no direct benefit to your health from taking part, but your contribution will help doctors improve care for other patients in the future.

What happens to the tissue they collect?

The tissue (which would normally be removed during your operation anyway) will be immediately studied in a lab to learn about its properties.

How to find out more

Andranik PETROSYAN, MD

andranik.petrosyan@chu-st-etienne.fr (0)477829505 Official trial record

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