The V-Wave Shunt: FIM Safety and Feasibility Study

N/ACompletedNCT01965015

V-Wave Ltd16 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Congestive Heart Failure

Interventions

Implantation of the V-Wave inter-atrial shuntDEVICE

Percutaneous implantation of the V-Wave shunt by right heart catheterization (RHC) approach

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (6)

Hamburg Universitary Cardiovascular Center

Hamburg, Germany

Arthur Kerner

Haifa, Israel

Rabin Medical Center, Cardiology Division

Petah Tikva, Israel

Universitario Valle de Hebron

Barcelona, Spain

Outcomes

Primary Outcomes

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

Time frame: 3 month

Secondary Outcomes

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

Time frame: 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

Time frame: 3 and 12 month

Data from ClinicalTrials.gov

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