The V-Wave Shunt: FIM Safety and Feasibility Study

Study Overview
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Brief Summary
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The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association (NYHA) class III -IV, Heart Failure (HF) patients. This is a First In Man (FIM) study, aimed to enable a first evaluation of the safety and performance of the V-Wave shunt implant when implanted in Chronic Heart Failure patients. Prospective, open label, single-arm study with intra-patient comparisons (i.e. subjects' status will be compared to their pre-implant (baseline) status.

Detailed Description
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V-Wave Ltd, an Israeli based medical device company, has developed the V-Wave atrial-septal shunt, a permanent implant indicated for Heart Failure (HF) patients with elevated Left Atrial filling Pressures (LAP). The V-Wave shunt, developed by V-Wave Ltd, has been designed specifically to meet the needs of an interatrial shunt and thus represents a dedicated device, to be implanted percutaneously in the interatrial septum creating an interatrial communication. This study aims to enable a first evaluation of the safety and performance of the V-Wave shunt implant when implanted in Heart Failure patients with elevated LAP. Study endpoints were then chosen to portray both safety (device related Major Adverse Cardiac And Neurological Events) as well as preliminary performance as assessed by a well characterized measure (e.g., LAP which is known to be associated with the general state of the disease and most importantly left ventricular ejection fraction and cardiac function in general).

Official Title
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The V-Wave Shunt For 'Left Atrial Decompression' In Patients With Advanced Chronic Heart Failure: FIM Safety and Feasibility Study

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: Implantation of the V-Wave inter-atrial shunt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 18 and < 85 years old Patient has chronic ischemic or non-ischemic cardiomyopathy NYHA Class III or ambulatory Class IV heart failure despite optimal medical therapy Patient LVEF > 15% and ≤ 40% Patient has elevated Left Atrial Pressure (LAP) Patient has normal Right Atrial Pressure (RAP) BNP or NTproBNP levels are >300 or >1500 pg/mL, respectively Exclusion Criteria: Right Heart Failure Ongoing malignant disease Thromboembolic event within the last 6 months Acute or chronic renal insufficiency Congenital heart disease Severe pulmonary hypertension Atrial Fibrillation (persistent/permanent) Severe Mitral Regurgitation LA Thrombus or Deep Vein Thrombosis (DVT) Severe restrictive or obstructive lung disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V-Wave shunt implant<br>Implantation of the V-Wave inter-atrial shunt | Device: Implantation of the V-Wave inter-atrial shunt<br>* Percutaneous implantation of the V-Wave shunt by right heart catheterization (RHC) approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall incidence of device related Major Adverse Cardiac and Neurological Events (MACNE) at 3 month post implantation | MACNE is defined as the composite rate of all death, stroke, device embolization, tamponade, and device related re-intervention or surgery | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall incidence of MACNE and Serious Adverse Device Events (SADEs) at 12 month post implantation | MACNE is defined as the composite rate of all death, stroke, device embolization, tamponade, and device related re-intervention or surgery | 12 month | 
| Reduction in Pulmonary Capillary Wedge Pressure (PCWP) | Reduction in PCWP as measured by Right Heart Catheterization (RHC) at 3 & 12 month post implantation | 3 and 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure (HF), Left Atrial Pressure