The V-Wave Shunt: FIM Safety and Feasibility Study

NCT01965015 | Completed

• 1 other identifier: VW-SP-1
• Study Type: interventional
• Target: 16
• Locations: 3 countries
• Sites: 6

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.

Conditions

Congestive Heart Failure

Keywords

Heart Failure (HF); Left Atrial Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall incidence of MACNE and Serious Adverse Device Events (SADEs) at 12 month post implantation

  12 month

• Reduction in Pulmonary Capillary Wedge Pressure (PCWP)

  3 and 12 month

Other Outcomes (1)

• Procedural success

  Implantation procedure

Study Arms (1)

V-Wave shunt implant

EXPERIMENTAL

Implantation of the V-Wave inter-atrial shunt

Device: Implantation of the V-Wave inter-atrial shunt

Interventions

Implantation of the V-Wave inter-atrial shunt DEVICE

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

V-Wave shunt implant

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• V-Wave Ltd: lead

Study Sites (6)

Hamburg Universitary Cardiovascular Center

Hamburg, 20246, Germany

Location

Arthur Kerner

Haifa, Israel

Location

Rabin Medical Center, Cardiology Division

Petah Tikva, 49100, Israel

Location

Universitario Valle de Hebron

Barcelona, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Clinicao Universitario de Valladolid

Valladolid, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rotem Katzenellenbogen

  V-Wave Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2013
• First Posted: October 18, 2013
• Study Start: April 1, 2014
• Primary Completion: January 21, 2016
• Study Completion: October 15, 2017
• Last Updated: October 7, 2019

Record last verified: 2018-04

Locations

ES (3); DE (1); IL (2)