RecruitingNAINTERVENTIONAL

LANDMARK Trial: a Randomised Controlled Trial of Myval THV

The LANDMARK Trial is a research study for people with a heart problem called aortic valve stenosis, where the main valve in your heart doesn't open properly. Doctors want to compare a new type of heart valve, called Myval THV, with two commonly used valves (Sapien THV and Evolut THV). The main aim is to check if the new valve is just as safe and effective as the older ones. Around 768 patients will take part, with half getting the Myval THV and the other half getting one of the other valves. Doctors will decide which valve a patient receives by chance, like flipping a coin. This helps make sure the study results are fair and reliable.

At a glance

Status

Recruiting

Phase

Sponsor

Meril Life Sciences Pvt. Ltd.

Enrolment target

988

Start

04 Nov 2020

Estimated completion

31 Dec 2033

Aortic Valve Stenosis

What is this study about?

The LANDMARK Trial is an important research study focused on helping people who have a condition called aortic valve stenosis. This happens when the heart's main valve, the aortic valve, becomes stiff and narrow. This makes it harder for your heart to pump blood around your body, which can cause symptoms like breathlessness, chest pain, and feeling tired.

Traditionally, surgery was often needed to replace this valve. However, over recent years, a less invasive procedure called Transcatheter Heart Valve (THV) replacement has become available. This involves replacing the valve using a thin tube guided into the heart, often through a blood vessel in the leg, without needing open-heart surgery.

This study is comparing a newer type of THV called Myval THV with two other well-established THVs (Sapien THV and Evolut THV) that doctors currently use. The main aim is to see if the Myval THV is as safe and works just as well as these existing options. By comparing them directly, researchers hope to provide more choices and better treatment options for people with aortic valve stenosis in the future. The study will also look at different sizes of these valves to ensure they fit a wide range of patients.

Key takeaways

The LANDMARK Trial compares a new heart valve (Myval THV) with existing ones.
It's for people with severe aortic valve stenosis.
Around 768 patients will take part, with valve choice made randomly.
The goal is to see if the new valve is just as safe and effective.
The procedure involves replacing the valve without open-heart surgery.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, you need to be at least 18 years old. You'll also need to chat with your medical team and sign a consent form, which explains everything about the study in detail. This ensures you understand what's involved and agree to take part.

Your heart care team will carefully check if you're suitable for a THV procedure and if all three types of valves being studied would be a good fit for you. They’ll also make sure there are no other health conditions that would make it unsafe for you to join the study.

However, you won't be able to join if you don't want to sign the consent form, or if your family members object to you taking part. Also, if your doctor believes that joining the study would be unsafe for you due to any other reason, you wouldn't be able to participate.

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 18 years old or older?
Have you discussed the study with your doctor and are willing to sign the consent form?
Has your heart team confirmed you are suitable for a THV procedure?
Are you suitable for any of the three types of valves being studied?
Do you have any other conditions that your doctor thinks might make joining unsafe?
Is your family okay with you taking part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned either the Myval THV or one of the other commonly used valves (Sapien THV or Evolut THV) by chance, much like drawing lots. You will not get to choose which valve you receive; this is done randomly to keep the study fair. All valve implantations will be performed using a thin tube inserted through a blood vessel, usually in your leg, as is standard practice for this type of procedure.

Before the procedure, you'll have various tests and assessments to make sure everything is ready. After the new valve is put in, you'll have regular check-ups and follow-up appointments with your medical team. These appointments will help them monitor your health and how well the new valve is working. The study will track your progress over a period, but the information provided doesn't specify the exact number of visits or the total duration of the follow-up. Your doctor will provide all the details about what to expect.

Potential risks and benefits

Taking part in this study might mean you receive the Myval THV, which could offer a new treatment option for your severe aortic valve stenosis. While the aim is for it to be as safe and effective as existing valves, there’s always a chance that a new treatment might have unexpected side effects or might not work as well for everyone. As with any medical procedure, there are potential risks associated with valve replacement, which your doctors will discuss fully with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care or your relationship with your medical team.

Locations (54)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Republican Scientific-Practical Centre "Cardiology"
Verified postcode
Minsk, Belarus· Not yet recruiting
Hospital Dante Pazanesse
Verified postcode
São Paulo, Brazil· Recruiting
Split Clinical Hospital Center
Verified postcode
Split, Croatia· Recruiting
University Hospital Dubrava Avenija Gojka Šuška 6
Verified postcode
Zagreb, Croatia· Recruiting
North Estonia Medical Center
Verified postcode
Tallinn, Estonia· Recruiting
Hôpital Henri Mondor
Verified postcode
Créteil, France· Recruiting
Lille University
Verified postcode
Lille, France· Recruiting
Institut Cardiovascular Paris-Sud
Verified postcode
Massy, France· Recruiting
Arnault Tzanck Institute
Verified postcode
Nice, France· Recruiting
Centre Hospitalier Universitaire De Rennes
Verified postcode
Rennes, France· Not yet recruiting
Kerckhoff-KlinikForschungs GmbH
Verified postcode
Bad Nauheim, Germany· Recruiting
Leipzig Heart Institute GmbH
Verified postcode
Leipzig, Germany· Recruiting

Common questions

What is aortic valve stenosis?

It's a condition where the main valve in your heart, called the aortic valve, becomes stiff and narrow, making it harder for your heart to pump blood.

What is a THV?

THV stands for Transcatheter Heart Valve. It's a way to replace a faulty heart valve using a thin tube, without needing open-heart surgery.

Will I get to choose which valve I receive?

No, the valve you receive will be chosen randomly, like drawing a name out of a hat, to ensure the study is fair.

What happens if I change my mind about being in the study?

You can leave the study at any time, for any reason, without it affecting your medical care.

Who is funding this research?

The information provided in the brief summary does not specify the funding source for this clinical trial.

How to find out more

Ashok Thakkar, PhD

ashok.thakkar@merillife.com +91-9879443584 Official trial record

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