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Edwards Cardioband Tricuspid Valve Reconstruction System 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.
 
ClinicalTrials.gov Identifier: NCT03382457
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
Early feasibility study to assess the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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, 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, 6 Months, 12 Months ]
    Increase in distance (m) from baseline

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

  4. Health Status [ Time Frame: 30 days, 6 Months, 12 Months ]
    Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire and 36 item short form survey (SF-36)



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)
  • Symptomatic despite medical therapy
  • 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
  • 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

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, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Lyndsay Christensen    312-694-0661    lyndsay.christensen@nm.org   
Contact: Caitlin Brady    312-926-5968    Cbrady1@nm.org   
Principal Investigator: Charles Davidson, MD         
Sub-Investigator: Mark Ricciardi, MD         
Sub-Investigator: James Thomas, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Craig Konwinski    507-255-6133    konwinski.craig@mayo.edu   
Contact: Structural Heart Research Team    507-255-6133      
Principal Investigator: Mackram Eleid, MD         
Sub-Investigator: Chranjit (Chet) Rihal, MD         
Sub-Investigator: John Stulak, MD         
Sub-Investigator: Juan Crestanello, MD         
Sub-Investigator: Grace Lin, MD         
Sub-Investigator: Mayra Guerrero, MD         
Sub-Investigator: Sorin Pislaru, MD         
Sub-Investigator: Vuyisile Nkomo, MD         
Sub-Investigator: Sunil Mankad, MD         
Sub-Investigator: Hector Michelena, MD         
Sub-Investigator: Tom Foley, MD         
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07962
Contact: Christine Ciprich    973-971-7541    Christine.ciprich@atlantichealth.org   
Contact: Tracy Oster    973-971-5951    Tracy.Oster@atlantichealth.org   
Principal Investigator: Robert Kipperman, MD         
Sub-Investigator: Philippe Genereux,, MD         
Sub-Investigator: Marc Goldschmidt, MD         
Sub-Investigator: John Brown, MD         
Sub-Investigator: Seth Uretsky, MD         
Sub-Investigator: Konstantinos Koulogiannis, MD         
Sub-Investigator: Leo Marcoff, MD         
Sub-Investigator: Lillian Aldaia, MD         
United States, New York
Columbia University Medical Center /New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Deniz Akkoc    212-305-7061    da2454@cumc.columbia.edu   
Contact: Lauren Privitera    212-342-3488    Lp2183@cumc.columbia.edu   
Sub-Investigator: Martin Leon, MD         
Sub-Investigator: Tamim Nazif, MD         
Sub-Investigator: Rebecca Hahn, MD         
Principal Investigator: Susheel Kodali, MD         
United States, Pennsylvania
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Susan K Herring, BSN, RN    484-476-8514    HerringS@mlhs.org   
Contact: Ann Marie Chikowski, BSN, RN    484-476-8579    ChikowskiA@mlhs.org   
Principal Investigator: William Gray, MD         
United States, Texas
Heart Hosiptal Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Brittany Zingler    469-814-4737    Brittany.Zingler@BSWHealth.org   
Contact: Necole Kell    469-814-4871    necole.kell@BSWHealth.org   
Principal Investigator: Robert Smith, MD         
Sub-Investigator: Molly Szerlip, MD         
Sub-Investigator: Paul Grayburn, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Linda Bailes, RN    434-982-1058    lgs2m@virginia.edu   
Contact: Jessica Morris    434-982-1058    jlm6uw@hscmail.mcc.virginia.edu   
Principal Investigator: Scott Lim, MD         
Sub-Investigator: Gorav Ailawadi, MD         
Sub-Investigator: Dale Fowler         
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: William Gray, MD Lankenau Heart, Wynnewood, PA

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03382457     History of Changes
Other Study ID Numbers: 2017-19
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
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