Edwards EVOQUE Eos MISCEND Study

Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02718001

Enrollment

123

Registered

2016-03-24

Start date

2015-02-06

Completion date

2033-04-30

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Keywords

Mitral, Regurgitation, Insufficiency, Degenerative, Functional, Primary, Secondary, Organic, Transcatheter, TMVR, TMVI, Heart Valve, Mitral Valve, Transseptal, Trans-Septal, Transeptal, Severe

Brief summary

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

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.

Interventions

DEVICEEdwards EVOQUE Eos Mitral Valve Replacement System

Replacement of the mitral valve through a transcatheter approach

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Unsuitable anatomy * Patient is inoperable

Design outcomes

Primary

Measure	Time frame	Description
Composite of major adverse events	30 days	Proportion of patients with major adverse events

Secondary

Measure	Time frame	Description
NYHA functional class	30 days, 6 Months, 12 Months, annual for five years	Number of patients with improvement in NYHA class
Six minute walk test	30 days, 6 Months, 12 Months, annual for five years	Increase in distance (m) from baseline
Reduction in MR grade	30 days, 6 Months, 12 Months, annual for five years	Number of patients with reduction in MR grade from baseline
Device Success	Immediately after procedure	Proportion of patients with device deployed as intended and delivery system successfully retrieved
Procedural Success	Discharge or 7 days post-procedure, whichever occurs first	Proportion of patients with device success without significant paravalvular leak
Clinical Success	30 days	Proportion of patients with procedural success without major adverse events

Countries

Canada, United States

Contacts

PRINCIPAL_INVESTIGATORRajendra Makkar, MD

Cedars-Sinai Medical Center, Los Angeles, CA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026