VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

NCT ID: NCT02113033

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-07
• Study Completion Date: 2016-09-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treated with Equilia system

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

Group Type: EXPERIMENTAL

Equilia® Vagal Nerve Stimulation

Intervention Type: DEVICE

Vagal Nerve Stimulation synchronized with cardiac activity

Interventions

Equilia® Vagal Nerve Stimulation

Vagal Nerve Stimulation synchronized with cardiac activity

Intervention Type: DEVICE

Other Intervention Names

Device used: Equilia®

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LivaNova

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albert Hagege, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

HEGP - Paris, France

Locations

UCL St Luc

Brussels, , Belgium

Hôpital Européen Georges Pompidou

Paris, , France

CHRU Hôpital Pontchaillou

Rennes, , France

CHU Rangueil

Toulouse, , France

Rikshospitalet

Oslo, , Norway

Dedinje Cardiovascular Institute

Belgrade, , Serbia

Countries

Belgium; France; Norway; Serbia

Other Identifiers

NVNS01

Identifier Type: -

Identifier Source: org_study_id