VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients (VANGUARD)

March 12, 2018 updated by: LivaNova
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • UCL St Luc
  • France
      • Paris, France, 75015
        • Hopital Europeen Georges Pompidou
      • Rennes, France, 35033
        • CHRU Hopital Pontchaillou
      • Toulouse, France, 31059
        • CHU Rangueil
  • Norway
      • Oslo, Norway, 0027
        • Rikshospitalet
  • Serbia
      • Belgrade, Serbia, 11040
        • Dedinje Cardiovascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Device used: Equilia®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Investigators

  • Principal Investigator: Albert Hagege, MD, PhD, HEGP - Paris, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 7, 2014

Primary Completion (ACTUAL)

February 22, 2016

Study Completion (ACTUAL)

September 20, 2016

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 11, 2014

First Posted (ESTIMATE)

April 14, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVNS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure With Reduced Ejection Fraction

Clinical Trials on Equilia® Vagal Nerve Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe