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Edwards Lifesciences CardiAQ™ Transcatheter Mitral Valve Replacement (TMVR) Early Feasibility Study

This study is currently recruiting participants.
Verified September 2017 by Edwards Lifesciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02718001
First Posted: March 24, 2016
Last Update Posted: September 4, 2017
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.
Information provided by (Responsible Party):
Edwards Lifesciences
  Purpose
Early feasibility study to evaluate the safety and function of the Edwards Lifesciences CardiAQ™ Transcatheter Mitral Valve

Condition Intervention Phase
Mitral Valve Regurgitation (Degenerative or Functional) Device: Transcatheter Mitral Valve Replacement (TMVR) Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transfemoral and Transapical Delivery Systems) For the Treatment of Moderate to Severe Mitral Regurgitation

Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • 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:
  • 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

  • Six minute walk test [ Time Frame: 30 days, 3 Months ,6 Months, 12 Months, annual for five years ]
    Increase in distance (m) from baseline

  • 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


Estimated Enrollment: 28
Study Start Date: February 2015
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Treatment with the Edwards Lifesciences CardiAQ™ Transcatheter Mitral Valve (transapical or transfemoral delivery)
Device: Transcatheter Mitral Valve Replacement (TMVR)
Replacement of the mitral valve through a transcatheter approach
Other Names:
  • CardiAQ™ Transcatheter Mitral Valve (TMV)
  • Edwards FORTIS™ Transcatheter Mitral Valve (TMV)

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 Lifesciences CardiAQ™ Transcatheter Mitral Valve with the Transfemoral and Transapical Delivery Systems.
  Eligibility

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.


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Unsuitable anatomy
  • Prohibitively high risk
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02718001


Contacts
Contact: Jill Trekell (949) 250-2672 jill_trekell@edwards.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Mane Arabyan Arabyan    310-248-8515    Mane.Arabyan@cshs.org   
Contact: Mitch Gheorghiu    (310) 423-6152    Mitch.Gheorghiu@cshs.org   
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    rguyton@emory.edu   
Contact: Vasilis Babaliaros, MD    404-712-7623    vbabali@emory.edu   
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    cbrady1@nm.org   
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    David.Heimansohn@stvincent.org   
Contact: James Hermiller, MD    (317) 583- 7804    herms2@gmail.com   
Principal Investigator: David Heimansohn, MD         
Principal Investigator: James Hermiller, MD         
United States, New York
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Elizabeth Haag, RN, BSN, MPA    516-562-6790    elizabeth.haag@chsli.org   
Contact: Lyn Santiago    516-562-6790    lyn.santiago@chsli.org   
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    melgaac@ccf.org   
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    Wilson.Szeto@uphs.upenn.edu   
Contact: Howard Herrmann, MD    215-410-6987    howard.herrmann@uphs.upenn.edu   
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    Elizabeth.P.Turrentine@uth.tmc.edu   
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    RobertL.Smith@baylorhealth.edu   
Contact: Molly Szerlip, MD    469-814-4871    Molly.Szerlip@baylorhealth.edu   
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    meredith.allen@imail.org   
Principal Investigator: Brian Whisenant, M.D.         
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: Robert Guyton, MD Emory University Hospital, Atlanta GA
Principal Investigator: James Hermiller, MD St. Vincent Heart Center, Indianapolis, IN
  More Information

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02718001     History of Changes
Other Study ID Numbers: 2013-05C
First Submitted: March 1, 2016
First Posted: March 24, 2016
Last Update Posted: September 4, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Edwards Lifesciences:
Mitral
Regurgitation
Insufficiency
Degenerative
Functional
Primary
Secondary
Organic
Transcatheter
TMVR
TMVI
Heart Valve
Mitral Valve
Transapical
Transseptal
Trans-Septal
Transeptal
Severe

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