Clinical trial NCT01965015: The V-Wave Shunt: FIM Safety and Feasibility Study
Official title: The V-Wave Shunt For 'Left Atrial Decompression' In Patients With Advanced Chronic Heart Failure: FIM Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Heart Failure (HF)
Left Atrial Pressure
Lead sponsor: V-Wave Ltd
Sponsor class: INDUSTRY
First posted: 2013-10-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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).

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

Primary outcomes:
measure: Overall incidence of device related Major Adverse Cardiac and Neurological Events (MACNE) at 3 month post implantation
timeFrame: 3 month
Secondary outcomes:
measure: Overall incidence of MACNE and Serious Adverse Device Events (SADEs) at 12 month post implantation
timeFrame: 12 month
measure: Reduction in Pulmonary Capillary Wedge Pressure (PCWP)
timeFrame: 3 and 12 month
Other outcomes:
measure: Procedural success
timeFrame: Implantation procedure
Locations:
city: Hamburg
country: Germany
facility: Hamburg Universitary Cardiovascular Center
city: Haifa
country: Israel
facility: Arthur Kerner
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Cardiology Division
city: Barcelona
country: Spain
facility: Universitario Valle de Hebron
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Valladolid
country: Spain
facility: Hospital Clinicao Universitario de Valladolid
Study officials:
affiliation: V-Wave Medical
name: Rotem Katzenellenbogen
role: STUDY_DIRECTOR
References: