The V-Wave Shunt: FIM Safety and Feasibility Study (VW-SP-1)

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

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.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Device: Implantation of the V-Wave inter-atrial shunt

Detailed Description

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
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Hamburg Universitary Cardiovascular Center
• Israel
  • Haifa, Israel
    • Arthur Kerner
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center, Cardiology Division
• Spain
  • Barcelona, Spain
    • Universitario Valle de Hebron
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Valladolid, Spain
    • Hospital Clinicao Universitario de Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Ability to successfully deliver (to the septal fossa ovalis) and deploy the V-Wave shunt	Implantation procedure

Collaborators and Investigators

• Sponsor: V-Wave Ltd
• Investigators: Study Director: Rotem Katzenellenbogen, V-Wave Medical

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): January 21, 2016
• Study Completion (Actual): October 15, 2017

Study Registration Dates

• First Submitted: October 12, 2013
• First Submitted That Met QC Criteria: October 14, 2013
• First Posted (Estimate): October 18, 2013

Study Record Updates

• Last Update Posted (Actual): October 7, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Heart Failure (HF); Left Atrial Pressure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: VW-SP-1