Active not recruitingNAINTERVENTIONAL

Edwards EVOQUE Eos MISCEND Study

This research study is investigating a new type of heart valve replacement system, called the Edwards EVOQUE Eos. It's designed for people who have a condition where their mitral valve, one of the main valves in the heart, is leaky. This leakiness can make people feel unwell. The study is specifically for those who might find traditional open-heart surgery too risky due to other health issues. Doctors involved in this study want to carefully check how safe the new valve is and how well it helps patients. The hope is that this new approach could offer a valuable alternative for people who currently have limited treatment options, helping to improve their heart function and overall well-being. It's a key step in understanding if this new device can make a positive difference.

At a glance

Status

Active not recruiting

Phase

Sponsor

Edwards Lifesciences

Enrolment target

123

Start

06 Feb 2015

Estimated completion

30 Apr 2033

Mitral Valve Regurgitation (Degenerative or Functional)

What is this study about?

This study is about a new way to treat a heart problem called mitral valve regurgitation. This means one of the main valves in your heart, the mitral valve, isn't closing properly, causing blood to leak backwards. This can make your heart work harder and lead to symptoms like feeling tired or breathless. Usually, a leaky mitral valve can be fixed with open-heart surgery, but for some people, this operation might be too risky because of their age or other health conditions.

This study is looking at a new device called the Edwards EVOQUE Eos Mitral Valve Replacement System. Instead of major open-heart surgery, this new valve can be put in using a less invasive method, often through a small cut or a blood vessel. The main goal of the study is to see if this new valve is safe for patients and if it works well to stop the leak and improve heart function. It's a way for doctors to gather important information about this new treatment.

By taking part, you would be helping doctors understand if this new heart valve can offer a safe and effective treatment option for people with leaky mitral valves who can't have traditional surgery. The results from studies like this are very important in making new treatments available to more patients in the future.

Key takeaways

This study is for people with a leaky mitral valve.
It's testing a new valve system (Edwards EVOQUE Eos).
It's mainly for patients who are too high-risk for open-heart surgery.
The goal is to check the new valve's safety and effectiveness.
Participation involves the valve implant and follow-up visits.

Who may be eligible?

To be able to take part in this study, you would need to have symptoms from a leaky mitral valve, which means it's considered to be significant. You would also need to be someone for whom open-heart surgery is considered too risky, perhaps because of other health problems you have.

Doctors will also need to check if your heart's anatomy (its structure) is suitable for this new type of valve. They have specific measurements and shapes they look for to make sure the device can be properly fitted.

If your heart structure isn't quite right for the device, or if your overall health means you're too unwell for any procedure, you might not be able to join the study. The study is for adults generally aged 18 and over, and both men and women can take part.

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.

Do you have a significant leaky mitral valve?
Has your doctor said open-heart surgery is too risky for you?
Are you 18 years old or older?
Have doctors said your heart’s shape could work with this new valve?
Are you currently not considered too unwell for any procedure?
Are you able to attend follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a thorough check-up to make sure this treatment is right for you. If suitable, you would then have the Edwards EVOQUE Eos valve implanted. This procedure typically involves a short hospital stay.

After the procedure, you would have regular follow-up visits with the study team. These visits will involve various tests, such as heart scans (like echocardiograms), blood tests, and physical examinations, to check how well the new valve is working and monitor your overall health.

The study team will provide you with a schedule for these visits, which will likely decrease in frequency over time. You may also be asked about your symptoms and how you feel. You won't be given any new study medication, as the focus is on the valve itself. The total duration of your participation will be explained to you, but typically medical device studies involve follow-up over several years to track long-term safety and performance.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be access to a new treatment that might improve your heart condition and quality of life, especially if other options are risky for you. However, as with any medical procedure, there are potential risks, such as bleeding, infection, or issues related to the valve implantation itself. The doctors 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 (19)

Sutter Mills-Peninsula
Verified postcode
Burlingame, United States
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States
Kaiser Permanente San Francisco
Verified postcode
San Francisco, United States
Emory University Hospital/Emory University Hospital Midtown
Verified postcode
Atlanta, United States
Northwestern University
Verified postcode
Chicago, United States
St. Vincent Heart Center
Verified postcode
Indianapolis, United States
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States
Morristown Medical Center
Verified postcode
Morristown, United States
St. Francis Hospital
Verified postcode
Roslyn, United States
Cleveland Clinic
Verified postcode
Cleveland, United States
Oregon Health & Science University
Verified postcode
Portland, United States
The Hospital of the University of Pennsylvania
Verified postcode
Philadelphia, United States

Common questions

What is a 'leaky mitral valve'?

It means one of the main valves in your heart isn't closing properly, allowing blood to flow backwards, which makes your heart work harder.

Why is this study important?

It's testing a new valve that could help people with a leaky mitral valve who are too unwell for traditional open-heart surgery.

Is this a new type of treatment?

Yes, the Edwards EVOQUE Eos is a new heart valve system being studied to see how safe and effective it is.

Will I have to have surgery?

The new valve is usually put in using a less invasive procedure, not traditional open-heart surgery, which is why it's being explored for those at high surgical risk.

Can anyone with a leaky valve join?

No, there are strict rules about who can take part, mainly for people at high risk for traditional surgery and whose heart structure suits the device.