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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 : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE December 19, 2017
First Posted Date  ICMJE December 26, 2017
Last Update Posted Date January 31, 2020
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
Freedom from device or procedure-related adverse events [ Time Frame: 30 days ]
Safety assessed by freedom from device or procedure-related adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2017)
Safety [ Time Frame: 30 days ]
Safety assessed by freedom from device or procedure-related adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2017)
  • NYHA Functional Class [ Time Frame: 30 days, 6 Months, 12 Months, annual for five years ]
    Number of patients with improvement in NYHA class
  • Six minute walk test [ Time Frame: 30 days, 6 Months, 12 Months ]
    Increase in distance (m) from baseline
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study
Official Title  ICMJE Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study
Brief Summary Early feasibility study to assess the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tricuspid Regurgitation
Intervention  ICMJE Device: Transcatheter Tricuspid Valve Reconstruction
Reconstruction of the tricuspid valve through a transcatheter approach
Other Name: Edwards Cardioband Tricuspid Valve Reconstruction
Study Arms  ICMJE Experimental: Treatment
Treatment with the Edwards Cardioband Tricuspid Valve Reconstruction System
Intervention: Device: Transcatheter Tricuspid Valve Reconstruction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2019)
35
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2017)
15
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: TMTT Clinical 949-250-2500 TMTT_Clinical@edwards.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03382457
Other Study ID Numbers  ICMJE 2017-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William Gray, MD Lankenau Heart, Wynnewood, PA
PRS Account Edwards Lifesciences
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP