Clinical Study of Edwards Cardioband Tricuspid Valve Reconstruction System

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

Detailed Description
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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

Official Title
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Clinical Study of Edwards Cardioband Tricuspid Valve Reconstruction System

Conditions
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Tricuspid Regurgitation

Intervention / Treatment
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* Device: Transcatheter Tricuspid Valve Reconstruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment with the Edwards Cardioband Tricuspid Valve Reconstruction System | Device: Transcatheter Tricuspid Valve Reconstruction<br>* Reconstruction of the tricuspid valve through a transcatheter approach<br>* Other names: Edwards Cardioband Tricuspid Valve Reconstruction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Major Adverse Event (MAE) Rate | Number and percentage of patients who experienced at least one major adverse event (MAE). | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success | Number and percentage of patients who had Device Success, definition modified from MVARC criteria. Per device analysis. | Intraprocedural | 
| Procedural Success | Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis. | Discharge (2-7 days) | 
| Clinical Success | Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional, TR, FTR, Transcatheter, Reconstruction