The ANTHEM-HF Study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with symptomatic heart failure.
Heart failure patients will be enrolled and randomized to cervical VNS implantation on either the left side or right side. After a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 6 months, with data collection at 3 months and 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Electrical Stimulation of the Vagus Nerve
Unnamed facility
Chennai, India
Cardiac Function
Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)
Time frame: 6 months
Adverse Events
Incidence of procedure and device-related complications
Time frame: 6 months
Functional Status
6-minute walk test
Time frame: 6 months
Quality of Life
Minnesota Living with Heart Failure Questionnaire
Time frame: 6 months
Functional Status
New York Heart Association Class
Time frame: 6 months
Autonomic Function
Heart Rate Variability (HRV)
Time frame: 6 months
Blood Biomarkers
Blood Levels of Heart Failure Biomarkers
Time frame: 6 months
Cardiac Function
Left ventricular end-systolic diameter (LVESD)
Time frame: 6 months
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