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Clinical Study of Edwards Cardioband Tricuspid Valve Reconstruction System

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.
 
ClinicalTrials.gov Identifier: NCT03382457
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : February 13, 2023
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:
Clinical Study of the Edwards Cardioband Tricuspid Valve Reconstruction System (formerly "Edwards Cardioband™ Tricuspid Valve Reconstruction System Early Feasibility Study")

Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Device: Transcatheter Tricuspid Valve Reconstruction Not Applicable

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 Cardioband Tricuspid Valve Reconstruction System
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Edwards Cardioband Tricuspid Valve Reconstruction System
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Treatment with the Edwards Cardioband Tricuspid Valve Reconstruction System
 Device: Transcatheter Tricuspid Valve Reconstruction
Reconstruction of the tricuspid valve through a transcatheter approach
Other Name: Edwards Cardioband Tricuspid Valve Reconstruction


Outcome Measures
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Primary Outcome Measures :
  1. Composite Major Adverse Event (MAE) Rate [ Time Frame: 30 days ]
    Number and percentage of patients who experienced at least one major adverse event (MAE).


Secondary Outcome Measures :
  1. Device Success [ Time Frame: Intraprocedural ]
    Number and percentage of patients who had Device Success, definition modified from MVARC criteria. Per device analysis.

  2. Procedural Success [ Time Frame: Discharge (2-7 days) ]
    Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis.

  3. Clinical Success [ Time Frame: 30 days ]
    Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis.


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Chronic functional tricuspid regurgitation (moderate or greater)
  • Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
  • The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid reconstruction

Exclusion Criteria:

  • Unsuitable anatomy
  • Primary tricuspid valve disease
  • Previous tricuspid valve repair or replacement with device in place
  • Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Contacts and Locations
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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): NCT03382457


Contacts
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Contact: TMTT Clinical 949-250-2500 TMTT_Clinical@edwards.com

Locations
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United States, Georgia
Piedmont Heart Institute Not yet recruiting
Atlanta, Georgia, United States, 30309
Principal Investigator: Vinod Thourani, MD         
Principal Investigator: Pradeep Yadav, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Charles Davidson, MD         
United States, Minnesota
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07962
Principal Investigator: Robert Kipperman, MD         
United States, New York
Columbia University Medical Center /New York Presbyterian Hospital Active, not recruiting
New York, New York, United States, 10032
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97293
Principal Investigator: Firas Zahr, MD         
United States, Pennsylvania
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Principal Investigator: William Gray, MD         
United States, Texas
Heart Hospital Baylor Plano Active, not recruiting
Plano, Texas, United States, 75093
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Principal Investigator: Brian Whisenant, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Principal Investigator: Scott Lim, MD         
United States, Washington
University of Washington Active, not recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: William Gray, MD Lankenau Heart
Principal Investigator: Firas Zahr, MD Oregon Health and Science University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03382457    
Other Study ID Numbers: 2017-19
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: February 13, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Edwards Lifesciences:
Functional
TR
FTR
Transcatheter
Reconstruction
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases