RecruitingNAINTERVENTIONAL

The ENCIRCLE Trial

This research study, called The ENCIRCLE Trial, is investigating a new treatment for a heart condition called mitral regurgitation (also known as mitral valve insufficiency). This is when one of the heart's valves, the mitral valve, doesn't close properly, causing blood to leak backward. We're testing a new device called the SAPIEN M3 System, which includes a replacement valve and a way to securely put it in place. This trial is specifically for individuals who have severe symptoms due to this leaking valve and for whom the usual surgical or other established treatments aren't suitable. The main goal is to find out if this new system is both safe and effective at helping patients with this condition.

At a glance

Status

Recruiting

Phase

Sponsor

Edwards Lifesciences

Enrolment target

900

Start

12 Nov 2020

Estimated completion

28 Feb 2031

Mitral Regurgitation Mitral Valve Insufficiency

What is this study about?

The ENCIRCLE Trial is a clinical study designed to evaluate a new treatment option for a common heart problem called mitral regurgitation. Imagine your heart as a house with several doors, or valves, that open and close to keep blood flowing in the right direction. The mitral valve is one of these important doors. In mitral regurgitation, this door doesn't close tightly, allowing some blood to leak backward each time your heart beats. This can make your heart work harder and lead to symptoms like breathlessness and tiredness.

For many people with this condition, there are well-established treatments, including open-heart surgery to repair or replace the valve, or less invasive procedures. However, for some individuals, these standard options might not be suitable due to other health issues, the specific shape of their heart, or other medical reasons. This is where the SAPIEN M3 System comes in. It's a new device, consisting of a replacement valve and a 'dock' to hold it securely in place, that doctors hope could offer an alternative for these patients.

The main purpose of this study is to carefully monitor people who receive the SAPIEN M3 System to see if it improves their symptoms, how well it works over time, and importantly, to make sure it's safe. It's a 'single-arm' study, meaning everyone in the study will receive the new treatment. This is a common way to study new devices when there isn't another suitable treatment option for the patients involved.

Key takeaways

This study evaluates a new device (SAPIEN M3 System) for severe mitral regurgitation.
It's for patients who cannot have standard heart valve treatments.
The goal is to check its safety and effectiveness.
Participation involves receiving the device and follow-up checks.
You'll receive close medical monitoring throughout the trial.

Who may be eligible?

To join this study, you must be 18 years old or older and have severe mitral regurgitation (meaning a significant leak in your mitral heart valve). You should also be experiencing symptoms like breathlessness, tiredness, or swelling, which doctors classify as NYHA functional class II or higher, even after your heart failure medications have been carefully managed and stable for at least a month.

A very important point is that a team of heart doctors must agree that the usual surgical or less invasive treatments for mitral regurgitation are not suitable for you. This could be due to your overall health, the specific shape of your heart, or other medical reasons.

There are also some reasons why you might not be able to join. For example, if your heart anatomy isn't suitable for the device, if you have other serious heart problems like poor heart pumping ability or severe issues with other heart valves, or if you've recently had a heart attack, stroke, or major surgery. Conditions like severe kidney or liver disease, uncontrolled lung disease, and active infections would also prevent you from taking part.

Quick self-check

Are you 18 years old or older?
Do you have a severe leak in your heart's mitral valve?
Are you having significant symptoms (like shortness of breath) even with stable medicine?
Has your heart care team said that standard treatments for your valve aren't suitable for you?
Do you have good general health otherwise, without other severe heart or organ problems?
Are you able to agree to take part and understand the study information?

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 The ENCIRCLE Trial, you would first go through a screening process to confirm you meet all the requirements. If you do, you would then receive the SAPIEN M3 System as part of a procedure. After the procedure, you'll have several follow-up appointments. These visits are important for the doctors to check how you're recovering, how the device is working, and how your symptoms are improving. You'll likely have various tests, such as heart scans, blood tests, and physical examinations, at these appointments.

The study involves regular check-ups over an extended period. This is to make sure your health is closely monitored for as long as possible after receiving the new device. You will be told the exact schedule of visits and tests during the consent process. The total duration of your participation in the study, including all follow-up, will be fully explained before you agree to join.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of this study is that the SAPIEN M3 System might improve your severe mitral regurgitation and help you feel better, especially if other standard treatments aren't an option for you. You would also receive very close medical attention and monitoring throughout the study. However, there are also risks. The procedure to implant the device carries potential risks, as does any medical procedure. These could include bleeding, infection, and potential complications related to the device itself. The SAPIEN M3 System is still being investigated, so its full effects and long-term performance are not yet completely known. It's crucial to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (68)

Heart Center Hospital
Huntsville, United States· Active not recruiting
Banner University Medical Center
Phoenix, United States· Active not recruiting
Saint Josephs Hospital Medical Center Dignity Health
Phoenix, United States· Active not recruiting
TMC Healthcare
Tucson, United States· Withdrawn
Scripps Health
La Jolla, United States· Active not recruiting
Good Samaritan Hospital
Los Angeles, United States· Active not recruiting
Cedars-Sinai Medical Center
Los Angeles, United States· Active not recruiting
Kaiser Sunset LA
Los Angeles, United States· Active not recruiting
Saint Joseph Hospital
Orange, United States· Withdrawn
California Pacific Medical Center
San Francisco, United States· Active not recruiting
UC Health Northern Colorado (Medical Center of the Rockies)
Loveland, United States· Active not recruiting
Delray Medical Center
Delray Beach, United States· Withdrawn

+56 more sites — see the official record for the full list.

Common questions

What is mitral regurgitation?

It's a heart condition where one of your heart valves (the mitral valve) doesn't close properly, causing blood to leak backward, making your heart work harder.

Why is this new device being tested?

It's being tested for people with severe mitral regurgitation who can't safely have standard surgical or other established treatments.

Will I get the new treatment if I join?

Yes, if you meet all the study requirements, you will receive the SAPIEN M3 System as part of this trial.

How long will I be in the study?

You will have follow-up appointments over an extended period, and the exact duration will be explained during the consent process.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your regular medical care.

How to find out more

Edwards TMTT Clinical Affairs

TMTT_Clinical@edwards.com +1 (949) 250-2500 Official trial record

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