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
Healthy heart vs. leaking mitral valve (MR)
Symptoms can include:
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
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
Are You a Candidate?
You may be eligible for this trial if you meet these key criteria:
- Your mitral valve isn’t working properly and leaking
- You are experiencing symptoms of your MR
- 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.
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 Trials.gov.
CAUTION – Investigational device. Limited by Federal (United States) law to investigational use.
Intended for US audiences only.
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