The V-Wave Shunt: FIM Safety and Feasibility Study

Congestive Heart Failure Clinical Trial

— VW-SP-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965015
• Other study ID #: VW-SP-1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: October 15, 2017

Study information

• Verified date: April 2018
• Source: V-Wave Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 15, 2017
• Est. primary completion date: January 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Implantation of the V-Wave inter-atrial shunt
Percutaneous implantation of the V-Wave shunt by right heart catheterization (RHC) approach

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
V-Wave Ltd

Countries where clinical trial is conducted

Germany,  Israel,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedural success	Ability to successfully deliver (to the septal fossa ovalis) and deploy the V-Wave shunt	Implantation procedure
Primary	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	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
Secondary	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