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Clinical Study of Edwards Cardioband Tricuspid Valve Reconstruction System

Primary Purpose

Tricuspid Regurgitation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcatheter Tricuspid Valve Reconstruction
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation focused on measuring Functional, TR, FTR, Transcatheter, Reconstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Piedmont Heart Institute
  • Northwestern University
  • Mayo Clinic
  • Morristown Medical Center
  • Columbia University Medical Center /New York Presbyterian Hospital
  • Oregon Health & Science University
  • Lankenau Medical Center
  • Heart Hospital Baylor Plano
  • Intermountain Medical Center
  • University of Virginia Health System
  • University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treatment with the Edwards Cardioband Tricuspid Valve Reconstruction System

Outcomes

Primary Outcome Measures

Composite Major Adverse Event (MAE) Rate
Number and percentage of patients who experienced at least one major adverse event (MAE).

Secondary Outcome Measures

Device Success
Number and percentage of patients who had Device Success, definition modified from MVARC criteria. Per device analysis.
Procedural Success
Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis.
Clinical Success
Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis.

Full Information

First Posted
December 19, 2017
Last Updated
September 5, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT03382457
Brief Title
Clinical Study of Edwards Cardioband Tricuspid Valve Reconstruction System
Official Title
Clinical Study of Edwards Cardioband Tricuspid Valve Reconstruction System
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation
Keywords
Functional, TR, FTR, Transcatheter, Reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment with the Edwards Cardioband Tricuspid Valve Reconstruction System
Intervention Type
Device
Intervention Name(s)
Transcatheter Tricuspid Valve Reconstruction
Other Intervention Name(s)
Edwards Cardioband Tricuspid Valve Reconstruction
Intervention Description
Reconstruction of the tricuspid valve through a transcatheter approach
Primary Outcome Measure Information:
Title
Composite Major Adverse Event (MAE) Rate
Description
Number and percentage of patients who experienced at least one major adverse event (MAE).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Device Success
Description
Number and percentage of patients who had Device Success, definition modified from MVARC criteria. Per device analysis.
Time Frame
Intraprocedural
Title
Procedural Success
Description
Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis.
Time Frame
Discharge (2-7 days)
Title
Clinical Success
Description
Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Gray, MD
Organizational Affiliation
Lankenau Heart
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Firas Zahr, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Columbia University Medical Center /New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97293
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33744150
Citation
Davidson CJ, Abramson S, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant BK, Puthumana J, Fowler D, Grayburn PA, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Deuschl F, Feldman T, Gray WA, Lim DS; Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study Investigators. Transcatheter Tricuspid Repair With the Use of 4-Dimensional Intracardiac Echocardiography. JACC Cardiovasc Imaging. 2022 Mar;15(3):533-538. doi: 10.1016/j.jcmg.2021.01.029. Epub 2021 Mar 17. No abstract available.
Results Reference
derived
PubMed Identifier
33413863
Citation
Davidson CJ, Lim DS, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant B, Puthumana J, Abramson S, Fowler D, Grayburn P, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Dahou A, Deo SH, Vandrangi P, Deuschl F, Feldman TE, Gray WA; Cardioband TR EFS Investigators. Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes. JACC Cardiovasc Interv. 2021 Jan 11;14(1):41-50. doi: 10.1016/j.jcin.2020.10.017.
Results Reference
derived

Learn more about this trial

Clinical Study of Edwards Cardioband Tricuspid Valve Reconstruction System

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