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Edwards EVOQUE Eos MISCEND Study

Primary Purpose

Mitral Valve Regurgitation (Degenerative or Functional)

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Edwards EVOQUE Eos Mitral Valve Replacement System
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation (Degenerative or Functional) focused on measuring Mitral, Regurgitation, Insufficiency, Degenerative, Functional, Primary, Secondary, Organic, Transcatheter, TMVR, TMVI, Heart Valve, Mitral Valve, Transseptal, Trans-Septal, Transeptal, Severe

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sutter Mills-Peninsula
  • Cedars-Sinai Medical Center
  • Kaiser Permanente San Francisco
  • Emory University Hospital/Emory University Hospital Midtown
  • Northwestern University
  • St. Vincent Heart Center
  • Beth Israel Deaconess Medical Center
  • Morristown Medical Center
  • St. Francis Hospital
  • Cleveland Clinic
  • Oregon Health & Science University
  • The Hospital of the University of Pennsylvania
  • The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
  • The Heart Hospital Baylor Plano
  • Intermountain Medical Center
  • University of Virginia Health System
  • St. Paul's Hospital
  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université Laval
  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treatment with the Edwards EVOQUE Eos mitral valve replacement system

Outcomes

Primary Outcome Measures

Composite of major adverse events
Proportion of patients with major adverse events

Secondary Outcome Measures

NYHA functional class
Number of patients with improvement in NYHA class
Six minute walk test
Increase in distance (m) from baseline
Reduction in MR grade
Number of patients with reduction in MR grade from baseline
Device Success
Proportion of patients with device deployed as intended and delivery system successfully retrieved
Procedural Success
Proportion of patients with device success without significant paravalvular leak
Clinical Success
Proportion of patients with procedural success without major adverse events

Full Information

First Posted
March 1, 2016
Last Updated
September 6, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT02718001
Brief Title
Edwards EVOQUE Eos MISCEND Study
Official Title
Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 6, 2015 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment with the Edwards EVOQUE Eos mitral valve replacement system
Intervention Type
Device
Intervention Name(s)
Edwards EVOQUE Eos Mitral Valve Replacement System
Other Intervention Name(s)
CardiAQ-Edwards™ Transcatheter Mitral Valve (TMV), Edwards FORTIS™ Transcatheter Mitral Valve (TMV), Transcatheter Mitral Valve Replacement (TMVR), Edwards EVOQUE Transcatheter Mitral Valve Replacement System
Intervention Description
Replacement of the mitral valve through a transcatheter approach
Primary Outcome Measure Information:
Title
Composite of major adverse events
Description
Proportion of patients with major adverse events
Time Frame
30 days
Secondary Outcome Measure Information:
Title
NYHA functional class
Description
Number of patients with improvement in NYHA class
Time Frame
30 days, 6 Months, 12 Months, annual for five years
Title
Six minute walk test
Description
Increase in distance (m) from baseline
Time Frame
30 days, 6 Months, 12 Months, annual for five years
Title
Reduction in MR grade
Description
Number of patients with reduction in MR grade from baseline
Time Frame
30 days, 6 Months, 12 Months, annual for five years
Title
Device Success
Description
Proportion of patients with device deployed as intended and delivery system successfully retrieved
Time Frame
Immediately after procedure
Title
Procedural Success
Description
Proportion of patients with device success without significant paravalvular leak
Time Frame
Discharge or 7 days post-procedure, whichever occurs first
Title
Clinical Success
Description
Proportion of patients with procedural success without major adverse events
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically significant, symptomatic mitral regurgitation High risk for open-heart surgery Meets anatomical criteria Exclusion Criteria: Unsuitable anatomy Patient is inoperable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajendra Makkar, MD
Organizational Affiliation
Cedars-Sinai Medical Center, Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sutter Mills-Peninsula
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Kaiser Permanente San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Emory University Hospital/Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
St. Vincent Heart Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université Laval
City
Québec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Edwards EVOQUE Eos MISCEND Study

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