An Investigation of a Therapy for Severe Mitral Regurgitation

If you or a loved one suffer from mitral regurgitation (MR), you are not alone. Nearly 1 in 10 adults suffers from the disease. Learn more about the investigational ENCIRCLE trial, and you may be able to help others like yourself


About the trial

The ENCIRCLE trial is studying the Edwards SAPIEN M3 system – a device designed to replace the mitral valve in patients with severe mitral regurgitation

This trial is meant for patients who are experiencing symptoms from their severe MR. Talk to your doctor to determine if this trial is right for you

What is mitral valve regurgitation

Mitral regurgitation (MR) also referred to as “leaky valve” occurs when the mitral valve in your heart does not close all the way. This allows blood to leak backward, and makes your heart work harder to pump enough blood to the rest of your body

Heart Icon

Healthy heart vs. leaking mitral valve (MR)

Degenerative mitral regurgitation slider (1/2) Healthy heart slider (2/2)
Healthy heart
Healthy heart
In a healthy heart, blood flows with continuous forward motion from the right side of the heart, passing through the lungs to collect oxygen, through the left side of the heart and mitral valve, then out to the rest of your body
Diseased heart
Diseased heart
There are a number of reasons why your mitral valve may be leaking: torn valve tissue, damage to the valve itself, and stretching due to an enlarged heart chamber are some of the possible reasons

Symptoms can include:

Shortness of breath
Shortness of breath
Inability to Exercise
Inability to Exercise
Fluid build up in the lower body
Fluid build up in the lower body
Feeling Tired
Feeling Tired

Typically, MR becomes more severe over time as your heart gets weaker from working harder, and if untreated can lead to heart failure or even death

What you should know about the ENCIRCLE trial

New medical devices are made available to people on a regular basis. However, before they can be offered to the public, they need to be studied for how safe they are and how well they work.

A clinical trial is a type of research conducted with volunteers that studies recently developed medical devices.

What is a clinical trial?

The ENCIRCLE clinical trial will evaluate an investigational device designed to treat severe MR by replacing your own mitral valve using a transcatheter procedure (no open-heart surgery)

  • This clinical study will allow doctors to understand how the SAPIEN M3 system works in patients like you
What is the ENCIRCLE trial?

Often patients are curious what is involved by participating in a clinical trial. While every experience is unique, you can expect the following milestones on your treatment journey

  • You must provide consent to your doctor that you’d like to participate
  • Your doctor will need to run some tests and collect imaging to determine the suitability of your heart for this device
  • Your doctor will review your medications and medical history to see if you are eligible
  • You will then be evaluated by a team of cardiology experts to determine if this is a treatment option for you
  • You will undergo the SAPIEN M3 procedure
  • After the procedure, your health will be monitored throughout the clinical trial and after implantation of the device. This will require you to come in for several follow-up visits over a 5-year period
  • During the trial, you will have a team of experts—your Heart Team—to guide and support you from beginning to end. You can count on them to answer any questions and work closely with your doctor to provide care
What can you expect?
  • The tests or procedures required by the clinical trial that would not otherwise be part of your standard care will be covered by Edwards Lifesciences, the sponsor of this trial
  • You will still be responsible for the cost of your usual ongoing medical care, including deductibles and co-payments that would be billed to you or your health insurance provider
What are the costs?

The Edwards SAPIEN M3 System

The SAPIEN M3 system is designed to replace your mitral valve through a minimally invasive procedure called transcatheter mitral valve replacement

Edwards SAPIEN M3 System

Are You a Candidate?

You may be eligible for this trial if you meet these key criteria:

  1. Your mitral valve isn’t working properly and leaking
  2. You are experiencing symptoms of your MR
  3. Your doctor determines any prior mitral interventions you may have had or attempted do not impact this new valve from working properly

Talk to your doctor to see if this trial is right for you

Ask your doctor or research coordinator for the full list of criteria. If you choose to participate, you will be asked to complete health and imaging assessments to ensure you meet the criteria to continue in the clinical trial.

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Support Agent

We’re here for you

We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center. For details about the trial, visit NCT04153292 at Clinical

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Give us a call
(888) 713-1564

CAUTION – Investigational device. Limited by Federal (United States) law to investigational use.
Intended for US audiences only.

CAUTION – Investigational device. Limited by Federal (United States) law to investigational use.
Intended for US audiences only.

© 2021 Edwards Lifesciences Corporation. All rights reserved.

Edwards Lifesciences ∙ One Edwards Way, Irvine CA 92614 USA

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