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VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients (VANGUARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02113033
Recruitment Status : Completed
First Posted : April 14, 2014
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
LivaNova

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure With Reduced Ejection Fraction Device: Equilia® Vagal Nerve Stimulation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Equilia VNS device
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
Actual Study Start Date : October 7, 2014
Actual Primary Completion Date : February 22, 2016
Actual Study Completion Date : September 20, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Treated with Equilia system
Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead
Device: Equilia® Vagal Nerve Stimulation
Vagal Nerve Stimulation synchronized with cardiac activity
Other Name: Device used: Equilia®




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by LVEF < 40%
  2. Chronic heart failure with symptoms characterized by NYHA functional class II or III at the time of enrollment despite optimal drug regimen
  3. Optimal drug regimen as defined in the current European guidelines
  4. Sinus rhythm, with spontaneous heart rate ≥ 60bpm at the time of enrollment
  5. Signed and dated informed consent

Main Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113033


Locations
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Belgium
UCL St Luc
Bruxelles, Belgium, 1200
France
Hôpital Européen Georges Pompidou
Paris, France, 75015
CHRU Hôpital Pontchaillou
Rennes, France, 35033
CHU Rangueil
Toulouse, France, 31059
Norway
Rikshospitalet
Oslo, Norway, 0027
Serbia
Dedinje Cardiovascular Institute
Belgrade, Serbia, 11040
Sponsors and Collaborators
LivaNova
Investigators
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Principal Investigator: Albert Hagege, MD, PhD HEGP - Paris, France
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Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT02113033    
Other Study ID Numbers: NVNS01
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases