The V-Wave Shunt: FIM Safety and Feasibility Study | NCT01965015

Studies
The V-Wave Shunt: FIM Safety and Feasibility Study

NCT01965015

Sponsor

V-Wave Ltd

Status

Completed

Last Update Posted

Oct 7, 2019Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Congestive Heart Failure

Interventions

Implantation of the V-Wave inter-atrial shunt

Countries

Germany
Israel
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2014Actual

Primary Completion Date

Jan 21, 2016Actual

Completion Date

Oct 15, 2017Actual

First Submitted Date

Oct 12, 2013

First Submission Date that Met QC Criteria

Oct 14, 2013

First Posted Date

Oct 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2019

Last Update Posted Date

Oct 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
V-Wave shunt implant	Experimental	Implantation of the V-Wave inter-atrial shunt	Device: Implantation of the V-Wave inter-atrial shunt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rotem Katzenellenbogen	V-Wave Medical	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamburg Universitary Cardiovascular Center		Hamburg		20246	Germany
Arthur Kerner

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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Browse Branches

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