Active not recruitingNAINTERVENTIONAL

AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System

This study, called AHEAD, is looking into a new device called the Cardiovalve Transfemoral Mitral Valve System. This device is designed to help people with severe mitral regurgitation, which is when the heart's mitral valve leaks badly. The study will check how safe the Cardiovalve is and how well it works to reduce the leaking. It's particularly designed for patients who can't safely undergo more common open-heart surgery. Researchers will gather information on its safety and performance within 30 days of the procedure, and then follow participants for up to two years to see the longer-term results. The aim is to find easier and safer ways to help people with this heart condition.

At a glance

Status

Active not recruiting

Phase

Sponsor

Cardiovalve Ltd.

Enrolment target

Start

23 Apr 2018

Estimated completion

31 Dec 2030

Mitral Regurgitation Mitral Valve Disease

What is this study about?

The AHEAD study is looking into a new way to treat a heart condition called mitral regurgitation. This happens when one of your heart valves, called the mitral valve, doesn't close properly, causing blood to leak backwards. This can make your heart work harder and lead to symptoms like breathlessness and tiredness. Normally, severe cases might need open-heart surgery, but for some people, this surgery is too risky because of their age or other health problems.

This new treatment involves a device called the Cardiovalve. It's quite innovative because it can be put in place without major surgery. Instead, doctors guide the new valve through a blood vessel in your leg (the femoral artery) all the way to your heart. It's designed to replace your faulty mitral valve, hopefully reducing the leak and easing the strain on your heart. This method aims to make the procedure much less invasive, which could mean a quicker recovery and fewer risks compared to traditional surgery.

The study's main goal is to see if this new Cardiovalve device is safe to use and how effective it is at stopping the leak. Researchers will closely watch patients for 30 days after the procedure, and then continue to follow them for up to two years. This long-term follow-up helps doctors understand how well the valve continues to work and if there are any long-term effects. If successful, this could offer a valuable new option for many people who currently have limited treatment choices for their severe mitral regurgitation.

Key takeaways

Tests a new, non-surgical approach for leaky heart valves.
Aims to help people who cannot have traditional open-heart surgery.
The new valve is inserted through a blood vessel in the leg.
The study assesses the safety and effectiveness of the Cardiovalve.
Participants will be followed for two years to track long-term results.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have severe mitral regurgitation, which means your heart's mitral valve is leaking badly. You should also be taking the best possible medication for your heart failure. A team of heart specialists will decide if traditional open-heart surgery is too risky for you, based on various health factors and scores.

There are also some specific requirements related to your heart and blood vessels. For instance, your heart's anatomy must be suitable for the Cardiovalve, and your blood vessels in the leg must allow for the device to be guided to your heart. You'll also need to be able to have certain types of heart scans.

However, some health conditions would prevent you from joining. For example, if you've recently had a stroke or heart attack, or if you've had previous heart valve surgery, you wouldn't be able to participate. Certain other heart conditions or recent surgeries could also make you ineligible. The doctors overseeing the study will check all these details to ensure the study is safe and appropriate 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 at least 18 years old?
Do you have a diagnosis of severe leaky heart valve (mitral regurgitation)?
Have heart doctors told you that open-heart surgery is too risky for you?
Are you able to attend follow-up hospital visits for two years?
Have you recently had a stroke or heart attack (within 3 months and 30 days, respectively)? (If yes to either, you likely can't join.)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first undergo a detailed assessment to ensure you meet all the requirements. If eligible, you would have the Cardiovalve device implanted via a small procedure, guided through a blood vessel in your leg. Doctors will carefully monitor you during and immediately after this procedure. You'll also be on standard medication for heart failure as needed.

After the procedure, you would have follow-up visits to the hospital at specific times over two years. These visits will help doctors check how you are recovering, how well the device is working, and if you're experiencing any issues. They will likely involve physical exams, heart scans like transesophageal echocardiography (TEE), and other tests to track your health progress and the device's performance. The total duration of your participation in the study would be two years from the time the device is implanted.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is receiving a new, less invasive treatment for your severe mitral regurgitation, which might improve your heart function and quality of life, especially if traditional surgery isn't an option for you. However, as this is a new procedure, there are potential risks associated with the implantation, such as bleeding, infection, or issues with the valve placement, though the study aims to carefully assess its safety. You will be closely monitored, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (11)

Universitätsklinikum Bonn
Verified postcode
Bonn, Germany
Herzzentrum der Uniklinik Köln
Verified postcode
Cologne, Germany
Studienzentrale der Medizinische Klinik II Universitäres Herzzentrum Lübeck
Verified postcode
Lübeck, Germany
Universitaet_Mainz
Verified postcode
Mainz, Germany
Klinikum der Universität München LMU
Verified postcode
München, Germany
Hygea
Verified postcode
Athens, Greece
Maria Cecilia Hospital
Verified postcode
Cotignola, Italy
Fondazione Toscana G. Monasterio-Ospedale del Cuore
Verified postcode
Massa, Italy
San Raffaele Hospital
Verified postcode
Milan, Italy
Policlinico San Donato
Verified postcode
Milan, Italy
A.O.U. Pisana
Verified postcode
Pisa, Italy

Common questions

What is mitral regurgitation?

Mitral regurgitation is a condition where the heart's mitral valve doesn't close properly, causing blood to leak backwards into a different part of the heart. This makes your heart work harder.

What is the Cardiovalve?

The Cardiovalve is a new artificial heart valve designed to replace a leaky mitral valve. It's special because it can be put into your heart using a small tube guided through a blood vessel in your leg, rather than requiring open-heart surgery.

Why is this study important?

This study is important because it's testing a less invasive way to treat severe mitral regurgitation, especially for people who are too unwell or at high risk for traditional open-heart surgery.

Will I have to pay to be in the study?

No, you will not have to pay for the study treatment or extra tests that are part of the research. Standard medical care costs would still apply.

How long does the study last?

If you join the study, you'll be followed for two years after the Cardiovalve device is put in place. This helps doctors understand its long-term effects.