VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients (VANGUARD)

LivaNova

Status and phase: Completed; Phase 2

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Device: Equilia® Vagal Nerve Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02113033

NVNS01

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Treated with Equilia system

Experimental group

Description:

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

Treatment:

Device: Equilia® Vagal Nerve Stimulation