Heart Failure With Reduced Ejection Fraction
Conditions
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.
Interventions
DEVICEEquilia® Vagal Nerve Stimulation
Vagal Nerve Stimulation synchronized with cardiac activity
Sponsors
LivaNova
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Equilia VNS device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium, France, Norway, Serbia
Outcome results
None listed