VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

Study Overview
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Brief Summary
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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.

Official Title
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VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

Conditions
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Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
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* Device: Equilia® Vagal Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Equilia VNS device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated with Equilia system<br>Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead | Device: Equilia® Vagal Nerve Stimulation<br>* Vagal Nerve Stimulation synchronized with cardiac activity<br>* Other names: Device used: Equilia®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |