VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

Phase 2

Completed

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Device: Equilia® Vagal Nerve Stimulation

• Registration Number: NCT02113033
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-11
• Study First Posted: 2014-04-14
• Study Start: 2014-10-07
• Primary Completion: 2016-02-22
• Study Completion: 2016-09-20
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-12
• Last Update Posted: 2018-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treated with Equilia system	Equilia® Vagal Nerve Stimulation	Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs.	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.

Trial Locations

Locations (6)

UCL St Luc; 🇧🇪 Bruxelles, Belgium

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

CHRU Hôpital Pontchaillou; 🇫🇷 Rennes, France

CHU Rangueil; 🇫🇷 Toulouse, France

Rikshospitalet; 🇳🇴 Oslo, Norway

Dedinje Cardiovascular Institute; 🇷🇸 Belgrade, Serbia