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Active, Not Recruiting

NCT Number: NCT02718001

Edwards EVOQUE Eos MISCEND Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mitral Valve Regurgitation (Degenerative or Functional) Cardiovascular Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heart Diseases Heart Valve Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mitral Valve Insufficiency Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unsuitable anatomy
  • Patient is inoperable

Treatment and study plan

Edwards EVOQUE Eos Mitral Valve Replacement System

Device

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

Primary outcomes

  1. Composite of major adverse events

    Time frame: 30 days

    Proportion of patients with major adverse events

Secondary outcomes

  1. NYHA functional class

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

    Number of patients with improvement in NYHA class

  2. Six minute walk test

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

    Increase in distance (m) from baseline

  3. Reduction in MR grade

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

    Number of patients with reduction in MR grade from baseline

  4. Device Success

    Time frame: Immediately after procedure

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

  5. Procedural Success

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

    Proportion of patients with device success without significant paravalvular leak

  6. Clinical Success

    Time frame: 30 days

    Proportion of patients with procedural success without major adverse events

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2028
Study completion
2033
First posted
Mar 24, 2016
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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