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Completed

NCT Number: NCT02113033

VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

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.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCL St Luc, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

  • 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

Treatment and study plan

Equilia® Vagal Nerve Stimulation

Device

Vagal Nerve Stimulation synchronized with cardiac activity

Other names: Device used: Equilia®

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

LivaNova

Industry

Registry information

Acronym: VANGUARD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 14, 2014
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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