Edwards EVOQUE Eos MISCEND Study

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

Detailed Description
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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.

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

Conditions
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Mitral Valve Regurgitation (Degenerative or Functional)

Intervention / Treatment
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* Device: Edwards EVOQUE Eos Mitral Valve Replacement System


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment with the Edwards EVOQUE Eos mitral valve replacement system | Device: Edwards EVOQUE Eos Mitral Valve Replacement System<br>* Replacement of the mitral valve through a transcatheter approach<br>* Other names: Edwards EVOQUE Transcatheter Mitral Valve Replacement System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of major adverse events | Proportion of patients with major adverse events | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral, Regurgitation, Insufficiency, Degenerative, Functional, Primary, Secondary, Organic, Transcatheter, TMVR, TMVI, Heart Valve, Mitral Valve, Transseptal, Trans-Septal, Transeptal, Severe