Heart Failure With Reduced Ejection FractionPhase 2VANGUARDNCT02113033
VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
A Phase 2 study testing Equilia® Vagal Nerve Stimulation in people with Heart Failure With Reduced Ejection Fraction, run by LivaNova at 6 sites in 4 countries.
Trial summary
The purpose of the VANGUARD study is to demonstrate the safety of Vagal Nerve Stimulation for the treatment of congestive heart failure with reduced ejection fraction, and to report secondary measures of efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Equilia® Vagal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 7 Oct 2014to 20 Sep 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by LVEF < 40%
- Chronic heart failure with symptoms characterized by NYHA functional class II or III at the time of enrollment despite optimal drug regimen
- Optimal drug regimen as defined in the current European guidelines
- Sinus rhythm, with spontaneous heart rate ≥ 60bpm at the time of enrollment
- Signed and dated informed consent
- Main Exclusion Criteria:
Show all 24Show fewer
- Patient implanted with or eligible to cardiac pacing as per current guideline
- Risk for neck surgery in the electrode zone within a year after enrollment
- Patient with right carotid artery stenosis
- Symptomatic hypotension
- History of peptic ulcer disease or upper gastrointestinal bleeding
- Asthma, severe COPD, or severe restrictive lung disease
- Advanced Diabetes Mellitus
- Recent acute myocardial infarction, coronary artery surgery or revascularization (or already planned)
- Recent cerebro-vascular event
- Significant valvulopathy
- Advanced Renal failure
- Previous heart transplant or current LVAD device therapy
- Life expectancy < 1 year for non-cardiac cause
- Patient included in another clinical study that could confound the results of this study
- Inability to understand the purpose of the study or to perform the procedures of the study
- Unavailability for scheduled follow-up
- Age of less than 18 years or under guardianship
- Pregnancy
Who cannot join
None listed.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
France3 sites
Hôpital Européen Georges Pompidou
Paris, 75015
CHRU Hôpital Pontchaillou
Rennes, 35033
CHU Rangueil
Toulouse, 31059
About this study
The purpose of the VANGUARD study is to demonstrate the safety of Vagal Nerve Stimulation for the treatment of congestive heart failure with reduced ejection fraction, and to report secondary measures of efficacy.
- Being tested
- Equilia® Vagal Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equilia® Vagal Nerve StimulationDevice
Also called Device used: Equilia®
Vagal Nerve Stimulation synchronized with cardiac activity
| Study group | Role | What they receive |
|---|---|---|
| Treated with Equilia system | Experimental | Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead Receives: Device: Equilia® Vagal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs.
Adverse device effects will be sub-classified into device-related or procedure-related, when the adverse event has a generic cause independent from the device itself and occurs within 30 days of the implant procedure.
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 posted14 Apr 2014 (estimated)
- Study start7 Oct 2014
- Primary completion22 Feb 2016
- Study completion20 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Equilia VNS device
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albert Hagege, MD, PhD, Principal investigator, HEGP - Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113033
- Sponsor's protocol ID
- NVNS01
- Acronym
- VANGUARD
- Status last verified
- Mar 2018
- First submitted
- 10 Apr 2014
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02113033
- Acronym / sponsor ID
- VANGUARD / NVNS01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2014 (actual)
- Primary completion
- 22 Feb 2016 (actual)
- Study completion
- 20 Sep 2016 (actual)
- First posted
- 14 Apr 2014 (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 purpose of the VANGUARD study is to demonstrate the safety of Vagal Nerve Stimulation for the treatment of congestive heart failure with reduced ejection fraction, and to report secondary measures of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Equilia VNS device
| Arm | Type | Receives |
|---|---|---|
| Treated with Equilia system | Experimental | Device: Equilia® Vagal Nerve StimulationImplantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by LVEF < 40%
- Chronic heart failure with symptoms characterized by NYHA functional class II or III at the time of enrollment despite optimal drug regimen
- Optimal drug regimen as defined in the current European guidelines
- Sinus rhythm, with spontaneous heart rate ≥ 60bpm at the time of enrollment
- Signed and dated informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Equilia® Vagal Nerve StimulationAlso: Device used: Equilia®Vagal Nerve Stimulation synchronized with cardiac activity | Device | Treated with Equilia system |
Primary outcome
The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs.
Time frame: 6 Months
Adverse device effects will be sub-classified into device-related or procedure-related, when the adverse event has a generic cause independent from the device itself and occurs within 30 days of the implant procedure.
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 13 Mar 2018.
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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.
Albert Hagege, MD, PhD principal investigator
HEGP - Paris, France
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Equilia® Vagal Nerve Stimulation in people with Heart Failure With Reduced Ejection Fraction, run by LivaNova at 6 sites in 4 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 24 inclusion and 0 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 13 Mar 2018. 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 France, Belgium, Norway, Serbia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs. (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 13 Mar 2018.