Edwards EVOQUE Eos MISCEND Study

April 8, 2026 updated by: Edwards Lifesciences

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval
      • Toronto, Canada
        • St. Michael's Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada
        • St. Paul's Hospital
  • United States
    • California
      • Burlingame, California, United States, 94010
        • Sutter Mills-Peninsula
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • San Francisco, California, United States, 94118
        • Kaiser Permanente San Francisco
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital/Emory University Hospital Midtown
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Heart Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
    • New York
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Hospital of the University of Pennsylvania
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Unsuitable anatomy
  • Patient is inoperable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Rajendra Makkar, MD, Cedars-Sinai Medical Center, Los Angeles, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2015

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2033

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimated)

March 24, 2016

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-05C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mitral Valve Regurgitation (Degenerative or Functional)

Clinical Trials on Edwards EVOQUE Eos Mitral Valve Replacement System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe