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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

Tracking Information
First Submitted Date  ICMJE April 10, 2014
First Posted Date  ICMJE April 14, 2014
Last Update Posted Date March 13, 2018
Actual Study Start Date  ICMJE October 7, 2014
Actual Primary Completion Date February 22, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
Official Title  ICMJE VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Equilia VNS device
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure With Reduced Ejection Fraction
Intervention  ICMJE Device: Equilia® Vagal Nerve Stimulation
Vagal Nerve Stimulation synchronized with cardiac activity
Other Name: Device used: Equilia®
Study Arms  ICMJE Experimental: Treated with Equilia system
Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead
Intervention: Device: Equilia® Vagal Nerve Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2018)
15
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 20, 2016
Actual Primary Completion Date February 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Norway,   Serbia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02113033
Other Study ID Numbers  ICMJE NVNS01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LivaNova
Study Sponsor  ICMJE LivaNova
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Albert Hagege, MD, PhD HEGP - Paris, France
PRS Account LivaNova
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP