VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02113033
• Date of registration: 10/04/2014
• Prospective Registration: Yes
• Primary sponsor: LivaNova
• Public title: VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients VANGUARD
• Scientific title: VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
• Date of first enrolment: October 7, 2014
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02113033
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium, France, Norway, Serbia

Contacts

• Name: Albert Hagege, MD, PhD
• Affiliation: HEGP - Paris, France

Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure With Reduced Ejection Fraction

Intervention(s)

Device: Equilia® Vagal Nerve Stimulation

Primary Outcome(s)

The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs. [Time Frame: 6 Months]

Secondary ID(s)

NVNS01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors