Chronic Heart FailureNCT02511912
Heart Failure (HF) Interatrial Shunt Study 1
A study testing V-Wave in people with Chronic Heart Failure, run by V-Wave Ltd at 1 site in Israel.
Trial summary
The objective of this study, is to assess the safety and performance of an interatrial shunt when implanted in patients with severe chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- V-Wave
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2017to May 2022
- 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
- Ischemic or non-ischemic cardiomyopathy with either reduced or preserved LV ejection fraction and documented heart failure for at least 6 months
- ACC/AHA Stage C, NYHA Class III or ambulatory Class IV heart failure,
- Receiving maximally tolerated medical therapy for heart failure as indicated per ACC/AHA or ESC Heart Failure Guidelines
- Subject has a minimum of one (1) prior hospital admission within the last 12 months for acute worsening of HF associated with signs/symptoms of congestion
- Able to perform the 6-minute walk test with a distance ≥150 meters and ≤450 meters.
- Provide written informed consent for study participation
Who cannot join
- Age <18 or >85 years old
- BMI <18 or >40 kg/m2
- systolic blood pressure <90 or >160 mmHg
- Has baseline 2-D echocardiographic evidence of, or history of, unresolved or non- organized intracardiac thrombus
- Has Pulmonary Hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg on screening baseline echocardiogram.
- Significant RV dysfunction defined echocardiographically as TAPSE <12mm or RVFAC ≤30%.
Show all 27Show fewer
- Left Ventricular End-Diastolic Diameter (LVEDD) > 8cm
- Has an Atrial Septal Defect or Patent Foramen Ovale with more than trace shunting on color Doppler or intravenous bubble study or prior surgical or interventional correction of congenital heart disease involving atrial septum including placement of a PFO or ASD closure device
- Had a Stroke, Transient Ischemic Attack, Systemic or Pulmonary Thromboembolism, or Deep Vein Thrombosis (DVT) within the last 6 months, or any prior stroke with permanent neurologic defect.
- Has untreated severe stenotic or regurgitant valve lesions, or coronary stenoses which are anticipated to require surgical or percutaneous intervention within 6 months, active valvular vegetations, atrial myxoma, hypertrophic cardiomyopathy with significant resting or provoked subaortic gradient, acute myocarditis, tamponade, or large pericardial effusion, constrictive pericarditis, infiltrative cardiomyopathy (including cardiac sarcoidosis, amyloidosis, and hemochromatosis), or congenital heart disease, as cause of HF.
- Transseptal procedure is anticipated within 6 months after the V-Wave Shunt implant.
- Bradycardia with heart rate <45 bpm (unless treated with a permanent pacemaker) or uncontrolled tachyarrhythmias.
- Intractable HF with resting symptoms despite maximal medical therapy (ACC/AHA HF Stage D).
- Intolerant to both ACEI and ARB and beta-blocker medical therapy for patients classified as HFrEF (EF ≤40%).
- Had an acute MI, Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), Rhythm Management system revision, lead extraction, or cardiac or other major surgery within 30 days.
- Not eligible for emergency open-heart, thoracic or vascular surgery in the event of cardiac perforation or other serious complication during contemplated study device implantation.
- Has a life expectancy <1 year due to non-cardiovascular illness.
- Has contraindications to all of the study-related anticoagulation/antiplatelet regimens
- Has an Estimated Glomerular Filtration Rate <30 ml/min/1.73 m2 by the MDRD method or is receiving dialysis.
- Hepatic impairment with at least one liver Function Test
- Severe chronic Pulmonary Disease
- Active infection requiring systemic antibiotics.
- Procedural (final) Exclusion Criteria:
- Unable to undergo both TEE and ICE.
- Anatomical anomaly on TEE or ICE
- Has inadequate vascular access for implantation of shunt.
- Hemodynamic anomaly or instability at time of FEC
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study, is to assess the safety and performance of an interatrial shunt when implanted in patients with severe chronic heart failure.
Read the detailed description
This is a prospective, non-randomized, open label, single-arm multi-center study assessing the performance and safety of the V-Wave inter-atrial unidirectional shunt when implanted in chronic heart failure patients with both reduced and preserved ejection fraction.
The V-Wave Interatrial Unidirectional Shunt is designed to enable blood flow in a controlled manner from the left atrium to the right atrium in heart failure patients where clinical sequelae such as symptomatic pulmonary congestion due to high left atrial filling pressure is common.
The objective of this study, is to assess the safety and performance of the V-Wave System when implanted in patients with severe chronic heart failure.
In addition, this study is designed, in-part, to collect a portion of the clinical data needed in support of a US FDA pivotal IDE study application to be submitted at a later date.
Up to 70 subjects with chronic ACC/AHA Stage C, NYHA functional class III or ambulatory class IV heart failure (HF), with reduced or preserved LV ejection fraction, who have a history of hospitalization for worsening HF or elevated ambulatory levels of BNP/NT-proBNP, in the setting of maximally tolerated guideline-directed HF drug and device therapy, will be enrolled in the study.
- Conditions
- Chronic Heart Failure
- Being tested
- V-Wave
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-WaveProcedure or surgery
The V-Wave shunt implantation procedure is a standard femoral venous access and inter-atrial septal puncture intervention. The shunt is placed through the Fossa Ovalis.
| Study group | Role | What they receive |
|---|---|---|
| V-Wave | Experimental | This is a single arm study, all eligible patients will receive the V-Wave implantable shunt.
The V-Wave device is implanted via standard femoral venous access and inter-atrial septal puncture intervention and is placed through the Fossa Ovalis. Receives: Procedure: V-Wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from study-related Major Adverse Cardiac and Neurological Events (MACNE)
MACNE is defined as the hierarchical composite of death, stroke, myocardial infarction, systemic embolic event or the requirement for surgical removal of the Study Device.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startMar 2017 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Why it stopped: Study was canceled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- V-Wave Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olivia Mishall, Study director, V-Wave Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511912
- Sponsor's protocol ID
- HF Study
- Status last verified
- Nov 2016
- First submitted
- 30 Jun 2015
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure (HF) Interatrial Shunt Study 1
- ClinicalTrials.gov ID
- NCT02511912
- Acronym / sponsor ID
- HF Study
- Conditions
- Chronic Heart Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was canceled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- V-Wave LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2017 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 30 Jul 2015 (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 objective of this study, is to assess the safety and performance of an interatrial shunt when implanted in patients with severe chronic heart failure.
Detailed description
This is a prospective, non-randomized, open label, single-arm multi-center study assessing the performance and safety of the V-Wave inter-atrial unidirectional shunt when implanted in chronic heart failure patients with both reduced and preserved ejection fraction.
The V-Wave Interatrial Unidirectional Shunt is designed to enable blood flow in a controlled manner from the left atrium to the right atrium in heart failure patients where clinical sequelae such as symptomatic pulmonary congestion due to high left atrial filling pressure is common.
The objective of this study, is to assess the safety and performance of the V-Wave System when implanted in patients with severe chronic heart failure.
In addition, this study is designed, in-part, to collect a portion of the clinical data needed in support of a US FDA pivotal IDE study application to be submitted at a later date.
Up to 70 subjects with chronic ACC/AHA Stage C, NYHA functional class III or ambulatory class IV heart failure (HF), with reduced or preserved LV ejection fraction, who have a history of hospitalization for worsening HF or elevated ambulatory levels of BNP/NT-proBNP, in the setting of maximally tolerated guideline-directed HF drug and device therapy, will be enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| V-Wave | Experimental | Procedure: V-WaveThis is a single arm study, all eligible patients will receive the V-Wave implantable shunt. The V-Wave device is implanted via standard femoral venous access and inter-atrial septal puncture intervention and is placed through the Fossa Ovalis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ischemic or non-ischemic cardiomyopathy with either reduced or preserved LV ejection fraction and documented heart failure for at least 6 months
- ACC/AHA Stage C, NYHA Class III or ambulatory Class IV heart failure,
- Receiving maximally tolerated medical therapy for heart failure as indicated per ACC/AHA or ESC Heart Failure Guidelines
- Subject has a minimum of one (1) prior hospital admission within the last 12 months for acute worsening of HF associated with signs/symptoms of congestion
- Able to perform the 6-minute walk test with a distance ≥150 meters and ≤450 meters.
Key exclusion criteria (27 listed)
- Age <18 or >85 years old
- BMI <18 or >40 kg/m2
- systolic blood pressure <90 or >160 mmHg
- Has baseline 2-D echocardiographic evidence of, or history of, unresolved or non- organized intracardiac thrombus
- Has Pulmonary Hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg on screening baseline echocardiogram.
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 |
|---|---|---|
| V-WaveThe V-Wave shunt implantation procedure is a standard femoral venous access and inter-atrial septal puncture intervention. The shunt is placed through the Fossa Ovalis. | Procedure or surgery | V-Wave |
Primary outcome
Freedom from study-related Major Adverse Cardiac and Neurological Events (MACNE)
Time frame: 6 months
MACNE is defined as the hierarchical composite of death, stroke, myocardial infarction, systemic embolic event or the requirement for surgical removal of the Study Device.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
Olivia Mishall study director
V-Wave Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V-Wave in people with Chronic Heart Failure, run by V-Wave Ltd at 1 site in Israel.
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 27 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: withdrawn, as of the sponsor's last update on 10 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 1 site in Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Freedom from study-related Major Adverse Cardiac and Neurological Events (MACNE) (time frame: 6 months). 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 10 Oct 2019.