Research Study: Encircle
Condition:
Mitral regurgitation
Study Sponsor: Edwards Lifesciences
Study Investigator: Paul Sorajja, MD
Study Contact: Stephannie Knutson
stephannie.knutson@allina.com
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.
Eligibility Criteria:

Inclusion Criteria:

  1. 18 years of age or older
  2. MR ≥ 3+
  3. NYHA functional class ≥ II
  4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
  5. Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment.
  6. The subject or subject's legal representative has been informed of the nature of the study, agrees

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!