Active not recruitingOBSERVATIONAL

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

This study, called MOMENTIS, is gathering information about a new heart valve called the MITRIS RESILIA Mitral Valve. It's designed to see how this new valve performs in everyday medical practice when used to replace a faulty mitral valve. Researchers want to understand if it's safe and if it works well for patients in the long term. This is an "observational" study, meaning doctors will simply watch and collect data on patients who receive the valve as part of their standard treatment, rather than assigning them to different treatments. Up to 500 patients from around the world will take part. The goal is to make sure this new valve helps people with mitral valve problems live healthier lives.

At a glance

Status

Active not recruiting

Sponsor

Edwards Lifesciences

Enrolment target

504

Start

11 Jan 2023

Estimated completion

01 Dec 2035

Mitral Stenosis Mitral Valve Insufficiency

What is this study about?

This study is about a new type of artificial heart valve called the MITRIS RESILIA Mitral Valve. Your heart has four valves that make sure blood flows in the right direction. The mitral valve is one of these, and if it doesn't work properly – either it's too narrow (mitral stenosis) or it leaks (mitral insufficiency) – it can cause serious health problems. When this happens, doctors sometimes need to replace the faulty valve with a new one.

This study is designed to carefully watch how the new MITRIS RESILIA valve performs in people who receive it during their heart surgery. It's not a study where people are given a new treatment just for research; instead, it's for people who would be having this valve fitted anyway as part of their regular medical care. The doctors will simply collect information about how the patients are doing after their surgery.

The main aim is to understand both the immediate safety of the valve after surgery and how well it continues to work over a longer period. By collecting information from up to 500 patients, researchers can get a good picture of the valve's real-world performance, helping to ensure it's a good option for future patients needing a mitral valve replacement.

Key takeaways

This study is observing how a new heart valve (MITRIS RESILIA) works in real patients.
It's for people who need their mitral valve replaced due to problems like narrowing or leaking.
You would receive the new valve as part of your standard heart surgery.
Doctors will collect information about your health over time to see how the valve performs.
The study aims to ensure the new valve is safe and effective in the long run.
Your participation helps improve understanding of new heart valve treatments.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and require surgery to replace your existing mitral valve – whether it's your natural valve or an artificial one that's no longer working. You also need to be able to understand the study information and agree in writing to take part, and be willing to follow the study's requirements.

There are certain reasons why someone might not be able to join. For example, if you've had a serious heart infection (endocarditis) in the last three months, or if you have severe kidney disease (Stage 4) or need dialysis, you wouldn't be eligible. Also, if doctors believe you have a life expectancy of less than two years because of a serious illness unrelated to your heart, you wouldn't be able to participate.

Finally, if your doctors believe the risks of the surgery are very high for you, based on special scoring systems or their own professional judgment (more than an 8% chance of death from the procedure), then this study would not be suitable.

Quick self-check

Are you 18 years old or older?
Do you need surgery to replace your mitral heart valve?
Are you able to agree in writing to take part and follow instructions?
Have you *not* had a serious heart infection in the last 3 months?
Do you *not* have severe kidney disease or need dialysis?
Do doctors believe your general life expectancy is at least two more years due to other health issues?

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

What does participation involve?

If you decide to take part in this study, it means that after you receive the MITRIS RESILIA Mitral Valve as part of your planned surgery, the doctors will regularly collect information about your health. This will involve your routine doctor's visits and check-ups related to your heart condition and the new valve. The study will look at both your immediate recovery after surgery and your long-term health. The total duration of your participation will depend on how long the researchers need to follow the performance of the valve, usually for several years, through your regular medical appointments.

Potential risks and benefits

Taking part in this study means that your doctors will closely monitor your health outcomes after receiving the MITRIS RESILIA valve, which could provide you with detailed information about your own recovery. However, there are no special benefits beyond receiving the best standard medical care for your condition. As with any medical procedure, there are always risks associated with heart valve replacement surgery itself, which your doctor will explain to you. There are no additional risks from simply having your health information collected for this observational study. You are free to withdraw from the study at any time without affecting your medical care.

Locations (34)

Hoag Memorial Hospital Presbyterian
Newport Beach, United States
Stanford University
Palo Alto, United States
AdventHealth Orlando
Orlando, United States
Piedmont Heart Institute
Athens, United States
Piedmont Heart Institute
Atlanta, United States
Ascension St. Vincent Heart Center
Carmel, United States
University of Michigan
Ann Arbor, United States
Mayo Clinic, Rochester
Rochester, United States
Washington University Barnes-Jewish Hospital
St Louis, United States
Mount Sinai Hospital
New York, United States
Columbia University Irving Medical Center
New York, United States
Weill Cornell Medicine
New York, United States

+22 more sites — see the official record for the full list.

Common questions

What is the mitral valve?

It's one of the four main valves in your heart. It makes sure blood flows in the right direction from one chamber to another.

What happens if my mitral valve doesn't work well?

It can either become too narrow (mitral stenosis) or leak blood (mitral insufficiency), which can make your heart work harder and cause health problems.

Is this a new type of heart surgery?

No, the study isn't about a new surgery technique. It's about a specific new artificial valve that doctors can use when replacing your mitral valve.

Will I get special treatment in this study?

You will receive the best possible care for your condition, which includes getting the MITRIS RESILIA valve if your doctors decide it's right for you. The study simply involves collecting information about your health outcomes after your surgery.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any point, and your decision will not affect the medical care you receive.