Edwards EVOQUE Eos MISCEND Study

Purpose

Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system

Condition

  • Mitral Valve Regurgitation (Degenerative or Functional)

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Clinically significant, symptomatic mitral regurgitation - High risk for open-heart surgery - Meets anatomical criteria

Exclusion Criteria

  • Unsuitable anatomy - Patient is inoperable

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment 		Treatment with the Edwards EVOQUE Eos mitral valve replacement system
  • Device: Edwards EVOQUE Eos Mitral Valve Replacement System
    Replacement of the mitral valve through a transcatheter approach
    Other names:
    • CardiAQ-Edwards™ Transcatheter Mitral Valve (TMV)
    • Edwards FORTIS™ Transcatheter Mitral Valve (TMV)
    • Transcatheter Mitral Valve Replacement (TMVR)
    • Edwards EVOQUE Transcatheter Mitral Valve Replacement System

More Details

Status
Active, not recruiting
Sponsor
Edwards Lifesciences

Study Contact

Detailed Description

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system.