Edwards EVOQUE Eos MISCEND Study

N/AActive Not RecruitingNCT02718001

Edwards Lifesciences123 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

123

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Interventions

Edwards EVOQUE Eos Mitral Valve Replacement SystemDEVICE

Replacement of the mitral valve through a transcatheter approach

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinically significant, symptomatic mitral regurgitation * High risk for open-heart surgery * Meets anatomical criteria Exclusion Criteria: * Unsuitable anatomy * Patient is inoperable

Locations (19)

Sutter Mills-Peninsula

Burlingame, California, United States

Cedars-Sinai Medical Center

Outcomes

Primary Outcomes

Composite of major adverse events

Proportion of patients with major adverse events

Time frame: 30 days

Secondary Outcomes

NYHA functional class

Number of patients with improvement in NYHA class

Time frame: 30 days, 6 Months, 12 Months, annual for five years

Six minute walk test

Increase in distance (m) from baseline

Time frame: 30 days, 6 Months, 12 Months, annual for five years

Reduction in MR grade

Number of patients with reduction in MR grade from baseline

Time frame: 30 days, 6 Months, 12 Months, annual for five years

Device Success

Proportion of patients with device deployed as intended and delivery system successfully retrieved

Time frame: Immediately after procedure

Procedural Success

Proportion of patients with device success without significant paravalvular leak

Time frame: Discharge or 7 days post-procedure, whichever occurs first

Clinical Success

Proportion of patients with procedural success without major adverse events

Time frame: 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.