Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation

Study Overview
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Brief Summary
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The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of moderate to severe tricuspid regurgitation (TR).

Official Title
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Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation

Conditions
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Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders

Intervention / Treatment
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* Device: VDyne Transcatheter Tricuspid Valve Replacement System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate or severe tricuspid valve regurgitation of primary or secondary etiology. Subject is adequately treated with medical therapy for heart failure 30 days prior to index procedure, including a diuretic. Heart Team determines patient is a recommended candidate for the VDyne System. Age 18 years or older. Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System. Exclusion Criteria: VDYNE SYSTEM SUITABILITY Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs Intolerance to procedural anticoagulation or post-procedural antiplatelet/anticoagulation regimen that cannot be medically managed Hypersensitivity to nickel or titanium CLINICAL EXCLUSION CRITERIA (assessed by pre-procedural imaging) Left Ventricular Ejection Fraction (LVEF) <30% Severe RV dysfunction Significant abnormalities of the tricuspid valve and sub-valvular apparatus. Sepsis including active infective endocarditis (IE) (within last 6 months) Right ventricular or atrial thrombus or vegetation Severe tricuspid annular or leaflets calcification Systolic pulmonary hypertension with systolic pulmonary artery pressure ≥70 mmHg. CONCOMITANT PROCEDURES Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease. Any planned surgery or interventional procedure within the period of 30 days prior to 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as CABG, PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound) Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure. Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure Prior tricuspid valve surgery or catheter-based therapy with permanent residual devices implanted that would preclude delivery or implantation of the VDyne Valve (e.g. valve replacement, edge to edge repair.) Severe valvular heart disease requiring intervention other than the tricuspid valve Known significant intracardiac shunt (e.g. septal defect) (PFO's without significant shunts are allowed) COMORBIDITIES Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure Severe lung disease (severe COPD or continuous use of home oxygen or oral steroids) Acute myocardial infarction (AMI) within 30 days Significant renal dysfunction (eGFR<30 ml/min/1.73m2) or on dialysis End-stage liver disease (MELD > 11 / CHILD class C) Bleeding requiring transfusion within 30 days Coagulopathy or other clotting disorder that cannot be medically managed Chronic immunosuppression or other condition that could impair healing response Any of the following: leukopenia, chronic anemia (Hgb < 9), thrombocytopenia, history of bleeding diathesis, or coagulopathy Unwilling to receive blood products GENERAL EXCLUSION CRITERIA Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically Life expectancy less than 12 months due to non-cardiac comorbidities Treatment is not expected to provide benefit (futile) Current IV Drug user (must be free drug abuse for > 1 year) Pregnant, lactating or planning pregnancy within next 12 months. (Female of child-bearing potential use two reliable contraceptive methods during the study - hormonal methods such as pill and condom). Vulnerable patient groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate, such as students, residents, and employees) Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study Patient (or legal guardian) unable or unwilling to provide written informed consent before study-specific procedures are conducted Patient unable or unwilling to comply with study required testing and follow-up visits.

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: VDyne System Treatment Arm<br> | Device: VDyne Transcatheter Tricuspid Valve Replacement System<br>* The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System which consists of a bioprosthetic implantable tricuspid valve, the VDyne Delivery System, Drop Tether, accessories that facilitate the placement of the valve and the VDyne Retrieval System. The VDyne Valve is deployed by transfemoral implantation within the native tricuspid valve and is implanted under fluoroscopic and transesophageal echocardiography (TEE) guidance, while the heart remains beating, without the use of CPB. The valve is repositionable and fully retrievable intraoperatively. Repositioning allows optimization of the valve position following deployment, and retrieval, with the VDyne Retrieval System, allows use of an alternative valve size or removal of the index VDyne Valve in the event of suboptimal valve delivery or other intraoperative complication.<br>* Other names: VDyne Valve;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) | The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC). | 30 days post-procedure | 
| Mortality | Mortality will be reported at 30 days post-procedure | 30 days post-procedure | 
| Device success | Rate of successful implantation of the VDyne Valve using the VDyne Delivery System | From implant start time to procedure room exit | 
| Procedural success | Rate of successful implantation of the VDyne Valve using the VDyne Delivery System & freedom from serious device and/or procedure-related adverse events | From implant start time to procedure room exit | 
| Change in tricuspid valve regurgitation as measured by the Imaging Core Labs | Change in tricuspid valve regurgitation as measured by the Imaging Core Labs | From Baseline to 1 month post-procedure | 
| Changes in quality of life as measured by the KCCQ changes. | Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome. | From Baseline to 1 month post-procedure | 
| Changes in functional capacity (6-minute walk test) | Changes in functional capacity (6-minute walk test) | From Baseline to 1 month post-procedure | 
| Changes in symptom status (NYHA class) | Changes in symptom status (NYHA class) | From Baseline to 1 month post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) | The percentage of subjects with Device- and/or Procedure related Major Adverse Events as classified by the CEC | From Baseline to 1 year post-procedure | 
| Change in tricuspid valve regurgitation as measured by the Imaging Core Lab | Change in tricuspid valve regurgitation as measured by the Imaging Core Lab | From Baseline to 3 months, 6 months and 1 year | 
| Rate of heart failure hospitalization | Rate of heart failure hospitalization | From Baseline to 3 months, 6 months and 1 year | 
| Changes in symptom status (NYHA class) | Changes in symptom status (NYHA class) | From Baseline to 3 months, 6 months and 1 year | 
| Changes in functional capacity (6 minute walk test) | Changes in functional capacity (6 minute walk test) | From Baseline to 3 months, 6 months and 1 year | 
| Changes in quality of life as measured by the KCCQ changes. | Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome. | From Baseline to 3 months, 6 months and 1 year |