TTVR Early Feasibility Study

Study Overview
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Brief Summary
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The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

Detailed Description
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Multi-center, prospective, non-randomized, investigational, and pre-market.

Official Title
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The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System

Conditions
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Tricuspid Regurgitation

Intervention / Treatment
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* Device: Intrepid™ TTVR System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE) New York Heart Association (NYHA) Function Class II or greater Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits Subject meets the legal minimum age to provide informed consent based on local regulatory requirements Exclusion Criteria: Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions) Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system Echocardiographic evidence of severe right ventricular dysfunction Left ventricular ejection fraction (LVEF) <30 as measured by resting echocardiogram within 30 days of the Index Procedure Need for emergent or urgent surgery Untreated clinically significant coronary artery disease requiring revascularization Carcinoid tricuspid regurgitation

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: Primary Cohort<br>Device: Intrepid TTVR System | Device: Intrepid™ TTVR System<br>* Device: Intrepid™ TTVR System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of implant or delivery related serious adverse events | Rate of implant or delivery related serious adverse events | Through 30 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC) | For procedural success to be present, device success must have been achieved without major clinical complications as detailed per clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement (part 2: endpoint definitions) | During Procedure | 
| Change in TR Grade from baseline | Change in TR Grade from baseline | Through 30 days post-procedure | 
| Rate of no significant TV stenosis | Rate of no significant TV stenosis | Through 30 days post-procedure | 
| Change in NYHA Class from baseline | Change in NYHA Class from baseline | Through 30 days post-procedure |