NCT02718001

Brief Summary

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
82mo left

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

19 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Feb 2015Apr 2033

Study Start

First participant enrolled

February 6, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2033

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

13.2 years

First QC Date

March 1, 2016

Last Update Submit

April 8, 2026

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Keywords

MitralRegurgitationInsufficiencyDegenerativeFunctionalPrimarySecondaryOrganicTranscatheterTMVRTMVIHeart ValveMitral ValveTransseptalTrans-SeptalTranseptalSevere

Outcome Measures

Primary Outcomes (1)

  • Composite of major adverse events

    Proportion of patients with major adverse events

    30 days

Secondary Outcomes (6)

  • NYHA functional class

    30 days, 6 Months, 12 Months, annual for five years

  • Six minute walk test

    30 days, 6 Months, 12 Months, annual for five years

  • Reduction in MR grade

    30 days, 6 Months, 12 Months, annual for five years

  • Device Success

    Immediately after procedure

  • Procedural Success

    Discharge or 7 days post-procedure, whichever occurs first

  • +1 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with the Edwards EVOQUE Eos mitral valve replacement system

Device: Edwards EVOQUE Eos Mitral Valve Replacement System

Interventions

Edwards EVOQUE Eos Mitral Valve Replacement SystemDEVICE

Replacement of the mitral valve through a transcatheter approach

Also known as: CardiAQ-Edwards™ Transcatheter Mitral Valve (TMV), Edwards FORTIS™ Transcatheter Mitral Valve (TMV), Transcatheter Mitral Valve Replacement (TMVR), Edwards EVOQUE Transcatheter Mitral Valve Replacement System
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unsuitable anatomy
  • Patient is inoperable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Sutter Mills-Peninsula

Burlingame, California, 94010, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Kaiser Permanente San Francisco

San Francisco, California, 94118, United States

Location

Emory University Hospital/Emory University Hospital Midtown

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

St. Vincent Heart Center

Indianapolis, Indiana, 46260, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

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

Houston, Texas, 77030, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

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

Québec, G1V 4G5, Canada

Location

St. Michael's Hospital

Toronto, Canada

Location

MeSH Terms

Conditions

Mitral Valve InsufficiencyGastroesophageal RefluxNeoplasm MetastasisLymphoma, Follicular

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Rajendra Makkar, MD

    Cedars-Sinai Medical Center, Los Angeles, CA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 24, 2016

Study Start

February 6, 2015

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2033

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(16)CA(3)