Condition: Mitral regurgitation
Key Inclusion Criteria:
- At least 18 years old
- Determined to be at high risk for mitral valve surgery
- Determined to be a candidate for transcatheter mitral valve replacement
Key Exclusion Criteria:
- EE is contraindicated, or screening transesophageal echo is unsuccessful or provides inadequate images for procedure guidance
- Anatomy preventing proper device deployment and function
- Mitral annular calcification that would prevent implantation or function of the device
Full Study Name
Edwards EVOQUE EOS Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device - MISCEND Study (IRB no. 40012)
This study focuses on adults who have been diagnosed with moderate or severe mitral regurgitation, a condition in which the mitral valve has become too loose and blood leaks back into one of the upper chambers of the heart. The purpose of the study is to evaluate the safety and performance of an investigational device called the Edwards EVOQUE Eos Mitral Valve Replacement System (EVOQUE Eos system) for patients with moderate to severe mitral valve regurgitation who are considered high-risk for open-heart surgery replacement and may experience a serious complication during surgery.
Standard of care for mitral valve replacement is open-heart surgery. However, this type of surgery can involve serious risks for patients who are older or have other heart disease and general health problems. The goal of the study is to assess the safety and performance of transfemoral (incision in the groin) implantation of the bioprosthetic (composed of biological and man‐made materials) mitral valve. The Edwards EVOQUE Eos System has been developed to replace the mitral valve without the need for open-heart surgery. Instead, the Edwards EVOQUE Eos Valve is implanted using a procedure called a transcatheter mitral valve (TMV) replacement.