The ANTHEM-HFpEF 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 with preserved and mid-range ejection fraction.
Heart failure patients will be enrolled and implanted with a cervical VNS system on the right side. After a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 12 months, with data collection at 3, 6, 9, and 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Electrical Stimulation of the Vagus Nerve
Krishna Institute of Medical Science
Secunderabad, India
Adverse Events
Incidence of procedure and device-related complications
Time frame: 12 months
Cardiac Size (LAVI)
Left atrial volume index
Time frame: 12 months
Functional Status (6MWD)
6-minute walk distance
Time frame: 12 months
Quality of Life Score
Minnesota Living with Heart Failure Questionnaire score
Time frame: 12 months
Functional Status (NYHA Class)
New York Heart Association classification
Time frame: 12 months
Cardiac Function (E/E')
Ratio of mitral velocity to early diastolic velocity of the mitral annulus
Time frame: 12 months
Cardiac Size (LV mass index)
Left ventricular mass index
Time frame: 12 months
Autonomic Function (HRV)
Heart rate variability
Time frame: 12 months
Blood Biomarkers
Blood Levels of Heart Failure Biomarkers (NT-proBNP, creatinine, C-reactive protein)
Time frame: 12 months
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