RecruitingOBSERVATIONAL

CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting

The MANTRA study is looking at heart valve devices made by a company called CORCYM. These devices are used to treat problems with the heart's valves in the aortic, mitral, and tricuspid areas. This is a "post-market" study, meaning the devices are already approved and in use. The main goal is to carefully watch how these devices perform in real patients over time, checking both their safety and how well they continue to work. It's a large, worldwide study, and it's set up to look at different CORCYM heart valve treatments under one main plan. The information gathered will help ensure these important devices continue to deliver good outcomes for patients.

At a glance

Status

Recruiting

Sponsor

Corcym S.r.l

Enrolment target

2,150

Start

29 Jun 2021

Estimated completion

31 Dec 2035

Cardiac Valve Disease

What is this study about?

Heart valve disease happens when one or more of the heart's four valves don't work correctly. This can affect how blood flows through the heart and to the rest of the body, making you feel tired, breathless, or have chest pain. If left untreated, it can lead to more serious heart problems. Thankfully, there are treatments available, including devices that can help replace or repair damaged heart valves.

The MANTRA study is focused on gathering more information about specific heart valve devices made by a company called CORCYM. These devices are already in use, and this study is like a long-term check-up to see how they perform in patients in the real world. It's not testing a new device that isn't yet approved; rather, it's about continuously ensuring the safety and effectiveness of approved treatments.

This study is quite large and organised under a main plan, which allows different types of CORCYM heart valve treatments – for the aortic, mitral, and tricuspid valves – to be studied. By collecting information from many patients at various hospitals, researchers can get a clear picture of how these important medical devices help people with heart valve disease over many years. This helps to ensure that patients continue to receive the best possible care.

Key takeaways

The MANTRA study monitors CORCYM heart valve devices already in use.
It aims to confirm long-term safety and how well the devices work.
It covers treatments for aortic, mitral, and tricuspid valve disease.
Participation involves routine medical check-ups for up to 10 years.
Your medical care is not changed by participating in the study.
Information gathered helps improve understanding of heart valve disease treatments.

Who may be eligible?

To be considered for this study, you would need to be suitable for treatment with one of CORCYM's heart valve devices for problems with your aortic, mitral, or tricuspid valves. The decision would be made by your doctor based on standard medical guidelines for using these devices.

You would also need to be willing to sign a consent form, showing you understand the study and agree to take part. Importantly, you would need to be able to attend all the scheduled follow-up appointments.

You would not be able to join the study if you are already involved in another clinical study that might interfere with the results of this one, or if your life expectancy is considered to be less than 12 months. Also, if there are any specific medical reasons why you shouldn't use CORCYM's devices, as outlined in their official instructions, you wouldn't be eligible.

Quick self-check

Are you suitable for a CORCYM heart valve device for aortic, mitral, or tricuspid valve issues?
Are you able to attend follow-up appointments for up to 10 years?
Are you NOT currently in another clinical study that might affect these results?
Do you have a life expectancy of more than 12 months?

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

What does participation involve?

If you take part in the MANTRA study, your medical information will be collected as part of your standard care during and after your heart valve procedure. There are no extra procedures or medications required specifically for the study.

The study involves several follow-up appointments. Initially, data will be collected around the time of your hospital discharge and then approximately 30 days after your procedure. After that, you will have annual check-ups for up to 10 years. During these appointments, information about your health, how the device is working, and any side effects will be gathered. You might also be asked to fill out questionnaires about your quality of life at the start of the study and at the 30-day follow-up. All of this information helps researchers understand the long-term performance and safety of the heart valve devices.

Potential risks and benefits

The MANTRA study aims to gather important information about the long-term safety and performance of heart valve devices that are already approved and in use. Taking part means contributing to a better understanding of how these treatments work for people in the real world, which can ultimately benefit future patients. There are no additional medical procedures or changes to your treatment plan directly because of the study. Your medical information will be collected during your standard care, so the risks are generally associated with your usual medical care for heart valve disease, rather than the study itself. You are always free to withdraw from the study at any time without affecting your medical treatment.

Locations (52)

St. Vincent Heart Center of Indiana
Indianapolis, United States· Recruiting
Ochsner Clinic Foundation
New Orleans, United States· Recruiting
Maine Medical Center
Portland, United States· Withdrawn
Duke University
Durham, United States· Recruiting
East Carolina University
Greenville, United States· Recruiting
University Hospitals Cleveland
Cleveland, United States· Recruiting
Cleveland Clinic
Cleveland, United States· Recruiting
University of Pennsylvania
Philadelphia, United States· Recruiting
Lankenau Institute for Medical Research
Wynnewood, United States· Active not recruiting
Innsbruck Medical University
Innsbruck, Austria· Recruiting
Ziekenhuis Oost Limburg
Genk, Belgium· Recruiting
UZ Gent
Ghent, Belgium· Recruiting

+40 more sites — see the official record for the full list.

Common questions

What is 'heart valve disease'?

It's when one or more of your heart's valves don't open or close properly, affecting blood flow. This can cause symptoms like tiredness or breathlessness.

Are the devices in this study new or experimental?

No, the CORCYM devices in this study are already approved and in use for treating heart valve disease. This study is tracking their long-term performance.

What does 'post-market' mean?

It means the medical devices are already available for use, and the study is gathering more information about their safety and how well they work once they are being used by patients in a real-world setting.

How long will I be followed in the study?

If you participate, you will have follow-up appointments for up to 10 years after your heart valve procedure.

Will taking part in this study change my medical treatment?

No, your medical treatment will be decided by your doctor as part of your usual care. This study simply collects information about that care and your health.

How to find out more

Silvia Dipinto

silvia.dipinto@corcym.com +39 346 1284042 Official trial record

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