Edwards EVOQUE Eos MISCEND Study

NCT ID: NCT02718001

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-06

Study Completion Date

2033-04-30

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.

Conditions

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Mitral Valve Regurgitation (Degenerative or Functional)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Treatment with the Edwards EVOQUE Eos mitral valve replacement system

Group Type EXPERIMENTAL

Edwards EVOQUE Eos Mitral Valve Replacement System

Intervention Type DEVICE

Replacement of the mitral valve through a transcatheter approach

Interventions

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Edwards EVOQUE Eos Mitral Valve Replacement System

Replacement of the mitral valve through a transcatheter approach

Intervention Type DEVICE

Other Intervention Names

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CardiAQ-Edwards™ Transcatheter Mitral Valve (TMV) Edwards FORTIS™ Transcatheter Mitral Valve (TMV) Transcatheter Mitral Valve Replacement (TMVR) Edwards EVOQUE Transcatheter Mitral Valve Replacement System

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rajendra Makkar, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center, Los Angeles, CA

Locations

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Sutter Mills-Peninsula

Burlingame, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Kaiser Permanente San Francisco

San Francisco, California, United States

Site Status

Emory University Hospital/Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

St. Vincent Heart Center

Indianapolis, Indiana, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Morristown Medical Center

Morristown, New Jersey, United States

Site Status

St. Francis Hospital

Roslyn, New York, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center

Houston, Texas, United States

Site Status

The Heart Hospital Baylor Plano

Plano, Texas, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

University of Virginia Health System

Charlottesville, Virginia, United States

Site Status

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université Laval

Québec, , Canada

Site Status

St. Michael's Hospital

Toronto, , Canada

Site Status

Countries

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United States Canada

Other Identifiers

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2013-05C

Identifier Type: -

Identifier Source: org_study_id

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