TRISCEND II Pivotal Trial

Study Overview
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Brief Summary
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Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Detailed Description
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The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

Official Title
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Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device

Conditions
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Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure

Intervention / Treatment
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* Device: Edwards EVOQUE System
* Drug: Optimal Medical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic tricuspid regurgitation (TR) despite medical therapy TR graded as severe or greater Appropriate for transcatheter tricuspid valve replacement per the local heart team Exclusion Criteria: Tricuspid valve anatomic contraindications Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months Hemodynamic instability Refractory heart failure requiring advanced intervention Currently participating in another investigational 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Edwards EVOQUE System & OMT<br>Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation | Device: Edwards EVOQUE System<br>* Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT<br>* Other names: Transcatheter tricuspid valve replacement;|
| Active Comparator: Optimal Medical Therapy (OMT)<br>Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation | Drug: Optimal Medical Therapy<br>* Optimal Medical Therapy<br>|
| Experimental: Single-Arm Registry<br>Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization | Device: Edwards EVOQUE System<br>* Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT<br>* Other names: Transcatheter tricuspid valve replacement;|
| Experimental: Continued Access Study<br>Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation. | Device: Edwards EVOQUE System<br>* Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT<br>* Other names: Transcatheter tricuspid valve replacement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TR Grade reduction and composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement | Comparison of number of participants with reduction in TR and composite endpoint event improvement between experimental and active comparator arms | 6 months | 
| Rate of Major Adverse Events (MAE) | Rate of Major Adverse Events (MAE) in experimental arm | 30 days | 
| Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6-minute walk distance improvement | Comparison of number of participants with composite endpoint events between experimental and active comparator arms | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint including reduction in TR grade, change in QOL from baseline, death and heart failure hospitalization, all-cause hospitalization, all-cause mortality, and change in right ventricular end diastolic volume index | Hierarchical comparison of number of participants with composite endpoint events between experimental and active comparator arms | 1 year |