RecruitingNAINTERVENTIONAL

Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

This study, called APOLLO-EU, is looking at a new treatment for people with a severe heart condition called mitral regurgitation. This is when the heart's mitral valve, which controls blood flow, becomes leaky. They are testing a new device called the Medtronic Intrepid™ TMVR TF System. This device is a replacement mitral valve that can be put into the heart without open-heart surgery, using a small tube (catheter). The study is for patients whose doctors believe they can't have traditional heart surgery or other approved catheter-based repairs. Researchers want to find out how safe and effective this new device is in improving symptoms and quality of life for these patients. It's a single-group study, meaning everyone in the study will receive the new device if they are suitable.

At a glance

Status

Recruiting

Phase

Sponsor

Medtronic Cardiovascular

Enrolment target

400

Start

07 Feb 2023

Estimated completion

01 Dec 2038

Mitral Regurgitation

What is this study about?

Your heart has four valves that act like one-way gates, making sure blood flows in the right direction. The mitral valve is one of these, located between two of the heart's chambers on the left side. With a condition called mitral regurgitation, this valve becomes leaky, causing blood to flow backward when your heart pumps. This makes your heart work harder and can lead to symptoms like shortness of breath and tiredness. In severe cases, it can significantly impact your health and daily life.

Traditionally, a leaky mitral valve might be fixed or replaced with open-heart surgery. However, for some people, surgery might be too risky due to other health issues. There are also other less invasive procedures that can repair the valve with a catheter, but these aren't suitable for everyone. This study is focusing on patients who fall into this group – those with severe symptoms whose doctors have decided that standard surgery or other approved catheter repairs aren't the best option for them.

The researchers are testing a new device called the Medtronic Intrepid™ TMVR TF System. This isn't a repair but a complete replacement of the leaky mitral valve. It's designed to be put into place using a catheter, meaning it avoids the need for major open-heart surgery. The aim of this study is to carefully check how safe this new device is and how well it works to help reduce the symptoms caused by a leaky mitral valve for these specific patients.

Key takeaways

Tests a new catheter-based mitral valve replacement.
For severe leaky heart valves when surgery isn't an option.
Aims to improve symptoms without open-heart surgery.
Careful checks on safety and effectiveness.
Requires regular follow-up appointments.

Who may be eligible?

To be considered for this study, you would need to have a seriously leaky mitral valve (moderate-to-severe or severe mitral regurgitation), or a moderately leaky valve combined with a condition called MAC (mitral annular calcification) where the valve area has hardened. Importantly, your heart specialist team would need to agree that conventional open-heart surgery or other approved catheter-based repairs are not suitable options for you.

There are also some general requirements, such as being at least 18 years old and being able to attend all follow-up appointments. The team will also need to ensure that the new device is a good fit for your heart's anatomy based on detailed scans.

However, you wouldn't be able to join the study if you have other serious health problems that might significantly shorten your life, such as certain advanced kidney or liver conditions. If you currently have an artificial heart valve from a previous surgery, or if you've had certain other heart procedures recently, you would also not be able to take part. There are also specific heart measurements, like how well your heart pumps or the size of a certain heart chamber, that would need to be within certain ranges for you to be eligible.

Quick self-check

Do I have a seriously leaky heart valve (mitral regurgitation)?
Has my heart team said that surgery or other catheter repairs aren't right for me?
Am I at least 18 years old?
Can I attend all required follow-up appointments?
Do I have any other major health problems that could significantly shorten my life?

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

What does participation involve?

If you are eligible and agree to take part in this study, the main intervention will be receiving the Medtronic Intrepid™ TMVR TF System. This procedure involves inserting the new valve using a thin, flexible tube called a catheter, usually through a blood vessel. Before and after the procedure, you will have various assessments to check your heart's health and symptoms. This will include heart scans, blood tests, and physical examinations. You will also have regular follow-up visits after the procedure to monitor your progress and the performance of the new valve. The study is designed to track your health and the device's function over time. The specific number and timing of follow-up visits will be explained to you in detail by the study team, and it's important you can commit to attending these. You will be free to withdraw from the study at any time.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is the chance to receive a new, less invasive treatment for your severe leaky mitral valve if existing treatments aren't suitable for you. This new valve might improve your symptoms and quality of life. However, as with any medical procedure, there are potential risks, including those associated with placing the device into the heart, such as bleeding, infection, or other complications. The study team will explain all known risks to you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (37)

Aarhus University Hospital
Aarhus, Denmark· Recruiting
Rigshospitalet
Copenhagen, Denmark· Recruiting
Odense University Hospital
Odense, Denmark· Recruiting
Clinique Pasteur
Toulouse, France· Recruiting
CHU Bordeaux
Bordeaux, France· Recruiting
Henri-Mondor University Hospital
Créteil, France· Recruiting
CHU Timone
Marseille, France· Recruiting
CHU de Nantes
Nantes, France· Recruiting
CHU Rennes - Pontchaillou Hospital
Rennes, France· Recruiting
Centre Cardiologique du Nord (CCN)
Saint-Denis, France· Recruiting
CHRU de Tours
Tours, France· Recruiting
Heart and Diabetes Center NRW
Bad Oeynhausen, Germany· Recruiting

+25 more sites — see the official record for the full list.

Common questions

What is mitral regurgitation?

It's when the heart's mitral valve doesn't close properly, causing blood to leak backward and making your heart work harder.

What is the Medtronic Intrepid™ system?

It's a new replacement heart valve that can be put into place using a small tube (catheter) instead of open-heart surgery.

Who is this study for?

It's for people with severe leaky mitral valves who cannot have other standard treatments like surgery or common non-surgical repairs.

Will I have open-heart surgery?

No, this procedure aims to replace the valve using a catheter, avoiding the need for traditional open-heart surgery.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, and it won't affect your medical care.

How to find out more

Hanne Gonnissen, PhD

rs.apolloeurope@medtronic.com +31 (0)43 356 6566 Official trial record

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