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Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study

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ClinicalTrials.gov Identifier: NCT03382457
Recruitment Status : Not yet recruiting
First Posted : December 26, 2017
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

December 19, 2017
December 26, 2017
May 24, 2018
May 2018
June 2020   (Final data collection date for primary outcome measure)
Freedom from device or procedure-related adverse events [ Time Frame: 30 days ]
Safety assessed by freedom from device or procedure-related adverse events
Safety [ Time Frame: 30 days ]
Safety assessed by freedom from device or procedure-related adverse events
Complete list of historical versions of study NCT03382457 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study
Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study
Early feasibility study to assess the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System
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
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Tricuspid Regurgitation
Device: Transcatheter Tricuspid Valve Reconstruction
Reconstruction of the tricuspid valve through a transcatheter approach
Other Name: Edwards Cardioband Tricuspid Valve Reconstruction
Experimental: Treatment
Treatment with the Edwards Cardioband Tricuspid Valve Reconstruction System
Intervention: Device: Transcatheter Tricuspid Valve Reconstruction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
15
Same as current
June 2024
June 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
No
Contact: Jill Trekell +1 (949) 250-2672 jill_trekell@edwards.com
United States
 
 
NCT03382457
2017-19
Yes
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
Plan to Share IPD: No
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: William Gray, MD Lankenau Heart, Wynnewood, PA
Edwards Lifesciences
May 2018

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