VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

NCT02113033 | Completed Phase 2 DMC

• 1 other identifier: NVNS01
• Study Type: interventional
• Target: 15
• Locations: 4 countries
• Sites: 6

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months

Study Arms (1)

Treated with Equilia system

EXPERIMENTAL

Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead

Device: Equilia® Vagal Nerve Stimulation

Interventions

Equilia® Vagal Nerve Stimulation DEVICE

Vagal Nerve Stimulation synchronized with cardiac activity

Also known as: Device used: Equilia®

Treated with Equilia system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LivaNova: lead

Study Sites (6)

UCL St Luc

Brussels, 1200, Belgium

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

CHRU Hôpital Pontchaillou

Rennes, 35033, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

Rikshospitalet

Oslo, 0027, Norway

Location

Dedinje Cardiovascular Institute

Belgrade, 11040, Serbia

Location

Study Officials

• Albert Hagege, MD, PhD

  HEGP - Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Equilia VNS device

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 14, 2014
• Study Start: October 7, 2014
• Primary Completion: February 22, 2016
• Study Completion: September 20, 2016
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

FR (3); BE (1); NO (1); SE (1)