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Edwards EVOQUE TMVR Early Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02718001
Recruitment Status : Recruiting
First Posted : March 24, 2016
Last Update Posted : January 25, 2019
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
Early feasibility study to evaluate the safety and function of the Edwards EVOQUE transcatheter mitral valve replacement system

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation (Degenerative or Functional) Device: Edwards EVOQUE Transcatheter Mitral Valve Replacement System Not Applicable

Detailed Description:
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and function of the Edwards EVOQUE transcatheter mitral valve replacement system.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility Study of the Edwards EVOQUE Transcatheter Mitral Valve Replacement System For the Treatment of Moderate to Severe Mitral Regurgitation
Study Start Date : February 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: Treatment
Treatment with the Edwards EVOQUE transcatheter mitral valve replacement system
Device: Edwards EVOQUE Transcatheter 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)

Primary Outcome Measures :
  1. Safety assessed by freedom from device or procedure-related adverse events [ Time Frame: 30 days ]
    Safety assessed by freedom from device- or procedure-related adverse events

Secondary Outcome Measures :
  1. NYHA functional class [ Time Frame: 30 days, 3 Months ,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, 3 Months ,6 Months, 12 Months, annual for five years ]
    Increase in distance (m) from baseline

  3. Reduction in MR grade [ Time Frame: 30 days, 3 Months ,6 Months, 12 Months, annual for five years ]
    Number of patients with reduction in MR grade from baseline

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Unsuitable anatomy
  • Patient is inoperable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02718001

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Contact: TMTT Clinical (949) 250-2500

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United States, California
Sutter Mills-Peninsula Recruiting
Burlingame, California, United States, 94010
Contact: Milena Ferreira    415-600-5707   
Contact: Alvina Singh    650-242-6278   
Principal Investigator: David Daniels, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Mane Arabyan Arabyan    310-248-8515   
Contact: Mitch Gheorghiu    (310) 423-6152   
Principal Investigator: Rajendra Makkar, MD         
Principal Investigator: Saibal Kar, MD         
Principal Investigator: Alfredo Trento, MD         
Principal Investigator: Daniel Ramzy, MD         
United States, Georgia
Emory University Hospital/Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30322
Contact: Robert Guyton, MD    404-712-7623   
Contact: Vasilis Babaliaros, MD    404-712-7623   
Principal Investigator: Robert Guyton, MD         
Principal Investigator: Vasilis Babaliaros, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Caitlin Brady    312-926-5968   
Principal Investigator: Charles Davidson, MD         
Principal Investigator: S.Chris Malaisrie, MD         
United States, Indiana
St. Vincent Heart Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: David Heimansohn, MD    317-583-7804   
Contact: James Hermiller, MD    (317) 583- 7804   
Principal Investigator: David Heimansohn, MD         
Principal Investigator: James Hermiller, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jenifer Kaufman, RN, MS    617-632-8956   
Contact: Trishna Sadhwani, BA    617-632-7485   
Principal Investigator: Jeffrey Popma, MD         
Sub-Investigator: Kamal Khabbaz, MD         
Sub-Investigator: David C Liu, MD         
Sub-Investigator: Senthil Nathan, MD         
Sub-Investigator: Duane Pinto, MD         
Sub-Investigator: Eli Gelfand, MD         
Sub-Investigator: Feroze Mahmood, MD         
Sub-Investigator: Roger Laham, MD         
Sub-Investigator: Diana Litmanovich, MD         
United States, New York
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Elizabeth Haag, RN, BSN, MPA    516-562-6790   
Contact: Lyn Santiago    516-562-6790   
Principal Investigator: George Petrossian, MD         
Principal Investigator: Newell Robinson, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Carrie Melgaard, MS, RT    216-444-8327   
Principal Investigator: Samir Kapadia, MD         
United States, Pennsylvania
The Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Wilson Szeto, MD    215-410-6987   
Contact: Howard Herrmann, MD    215-410-6987   
Principal Investigator: Wilson Szeto, MD         
Principal Investigator: Howard Herrmann, MD         
United States, Texas
The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Elizabeth Turrentine, MPH, CCRP    713-500-5683   
Principal Investigator: Richard Smalling, MD         
Principal Investigator: Pranav Loyalka, MD         
Principal Investigator: Biswajit Kar, MD         
Principal Investigator: Igor Gregoric, MD         
Principal Investigator: Tom C. Nguyen, MD         
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Robert Smith, MD    469-814-4871   
Contact: Molly Szerlip, MD    469-814-4871   
Principal Investigator: Robert Smith, MD         
Principal Investigator: Molly Szerlip, MD         
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Meredith Allen, CCRP    801-507-4769   
Principal Investigator: Brian Whisenant, M.D.         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Linda Bailes, RN    434-982-1058      
Contact: Jessica Morris    434-982-1058      
Principal Investigator: Scott Lim, MD         
Sub-Investigator: Gorav Ailawadi, MD         
Sub-Investigator: Dale Fowler, MD         
Sponsors and Collaborators
Edwards Lifesciences
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Principal Investigator: Robert Guyton, MD Emory University Hospital, Atlanta GA
Principal Investigator: James Hermiller, MD St. Vincent Heart Center, Indianapolis, IN

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Responsible Party: Edwards Lifesciences Identifier: NCT02718001     History of Changes
Other Study ID Numbers: 2013-05C
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Edwards Lifesciences:
Heart Valve
Mitral Valve

Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases