The V-Wave Shunt: FIM Safety and Feasibility Study

NCT ID: NCT01965015

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-01
• Study Completion Date: 2017-10-15

Brief Summary

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

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).

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

V-Wave shunt implant

Implantation of the V-Wave inter-atrial shunt

Group Type: EXPERIMENTAL

Implantation of the V-Wave inter-atrial shunt

Intervention Type: DEVICE

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

Interventions

Implantation of the V-Wave inter-atrial shunt

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

V-Wave Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rotem Katzenellenbogen

Role: STUDY_DIRECTOR

V-Wave Medical

Locations

Hamburg Universitary Cardiovascular Center

Hamburg, , Germany

Arthur Kerner

Haifa, , Israel

Rabin Medical Center, Cardiology Division

Petah Tikva, , Israel

Universitario Valle de Hebron

Barcelona, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Clinicao Universitario de Valladolid

Valladolid, , Spain

Countries

Germany; Israel; Spain

Other Identifiers

VW-SP-1

Identifier Type: -

Identifier Source: org_study_id