Congestive Heart FailureVW-SP-1NCT01965015
The V-Wave Shunt: FIM Safety and Feasibility Study
A study testing Implantation of the V-Wave inter-atrial shunt in people with Congestive Heart Failure, run by V-Wave Ltd at 6 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Implantation of the V-Wave inter-atrial shunt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Apr 2014to 15 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Right Heart Failure
- Ongoing malignant disease
- Thromboembolic event within the last 6 months
- Acute or chronic renal insufficiency
- Congenital heart disease
- Severe pulmonary hypertension
Show all 10Show fewer
- Atrial Fibrillation (persistent/permanent)
- Severe Mitral Regurgitation
- LA Thrombus or Deep Vein Thrombosis (DVT)
- Severe restrictive or obstructive lung disease
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Spain3 sites
Universitario Valle de Hebron
Barcelona
Hospital Clinico San Carlos
Madrid
Hospital Clinicao Universitario de Valladolid
Valladolid
Israel2 sites
Arthur Kerner
Haifa
Rabin Medical Center, Cardiology Division
Petah Tikva, 49100
About this study
Official title: The V-Wave Shunt For 'Left Atrial Decompression' In Patients With Advanced Chronic Heart Failure: FIM Safety and Feasibility Study
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.
Read the 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
- Being tested
- Implantation of the V-Wave inter-atrial shunt
- Keywords
- Heart Failure (HF), Left Atrial Pressure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of the V-Wave inter-atrial shuntDevice
Percutaneous implantation of the V-Wave shunt by right heart catheterization (RHC) approach
| Study group | Role | What they receive |
|---|---|---|
| V-Wave shunt implant | Experimental | Implantation of the V-Wave inter-atrial shunt Receives: Device: Implantation of the V-Wave inter-atrial shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 month
Secondary outcomes (2)
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
Measured: 12 month
Reduction in Pulmonary Capillary Wedge Pressure (PCWP)
Reduction in PCWP as measured by Right Heart Catheterization (RHC) at 3 \& 12 month post implantation
Measured: 3 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study start1 Apr 2014
- Primary completion21 Jan 2016
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- V-Wave Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rotem Katzenellenbogen, Study director, V-Wave Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965015
- Sponsor's protocol ID
- VW-SP-1
- Acronym
- VW-SP-1
- Status last verified
- Apr 2018
- First submitted
- 12 Oct 2013
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The V-Wave Shunt For 'Left Atrial Decompression' In Patients With Advanced Chronic Heart Failure: FIM Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT01965015
- Acronym / sponsor ID
- VW-SP-1 / VW-SP-1
- Conditions
- Congestive Heart Failure
- Keywords
- Heart Failure (HF), Left Atrial Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- V-Wave LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 21 Jan 2016 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| V-Wave shunt implant | Experimental | Device: Implantation of the V-Wave inter-atrial shuntImplantation of the V-Wave inter-atrial shunt |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- Right Heart Failure
- Ongoing malignant disease
- Thromboembolic event within the last 6 months
- Acute or chronic renal insufficiency
- Congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of the V-Wave inter-atrial shuntPercutaneous implantation of the V-Wave shunt by right heart catheterization (RHC) approach | Device | V-Wave shunt implant |
Primary outcome
Overall incidence of device related Major Adverse Cardiac and Neurological Events (MACNE) at 3 month post implantation
Time frame: 3 month
MACNE is defined as the composite rate of all death, stroke, device embolization, tamponade, and device related re-intervention or surgery
2 secondary outcomes
Overall incidence of MACNE and Serious Adverse Device Events (SADEs) at 12 month post implantation
Time frame: 12 month
Reduction in Pulmonary Capillary Wedge Pressure (PCWP)
Time frame: 3 and 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rotem Katzenellenbogen study director
V-Wave Medical
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of the V-Wave inter-atrial shunt in people with Congestive Heart Failure, run by V-Wave Ltd at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, Israel, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence of device related Major Adverse Cardiac and Neurological Events (MACNE) at 3 month post implantation (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.