Clinical Study of Edwards Cardioband Tricuspid Valve Reconstruction System

Tricuspid Regurgitation Clinical Trial

Official title:

Clinical Study of Edwards Cardioband Tricuspid Valve Reconstruction System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03382457
• Other study ID #: 2017-19
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: January 31, 2030

Study information

• Verified date: September 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: January 31, 2030
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Transcatheter Tricuspid Valve Reconstruction
Reconstruction of the tricuspid valve through a transcatheter approach

Locations

Country	Name	City	State
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Morristown Medical Center	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	Columbia University Medical Center /New York Presbyterian Hospital	New York	New York
United States	Heart Hospital Baylor Plano	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Washington	Seattle	Washington
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Major Adverse Event (MAE) Rate	Number and percentage of patients who experienced at least one major adverse event (MAE).	30 days
Secondary	Device Success	Number and percentage of patients who had Device Success, definition modified from MVARC criteria. Per device analysis.	Intraprocedural
Secondary	Procedural Success	Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis.	Discharge (2-7 days)
Secondary	Clinical Success	Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis.	30 days