Congestive Heart Failure
Conditions
Keywords
Heart Failure, Preserved Ejection Fraction, VNS, Vagus Nerve, Autonomic Regulation Therapy
Brief summary
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.
Detailed description
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.
Interventions
Electrical Stimulation of the Vagus Nerve
Sponsors
Cyberonics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with preserved and mid-range EF (≥40%).
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 12 months | Incidence of procedure and device-related complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Status (6MWD) | 12 months | 6-minute walk distance |
| Quality of Life Score | 12 months | Minnesota Living with Heart Failure Questionnaire score |
| Functional Status (NYHA Class) | 12 months | New York Heart Association classification |
| Cardiac Size (LAVI) | 12 months | Left atrial volume index |
| Cardiac Size (LV mass index) | 12 months | Left ventricular mass index |
| Autonomic Function (HRV) | 12 months | Heart rate variability |
| Blood Biomarkers | 12 months | Blood Levels of Heart Failure Biomarkers (NT-proBNP, creatinine, C-reactive protein) |
| Cardiac Function (E/E') | 12 months | Ratio of mitral velocity to early diastolic velocity of the mitral annulus |
Countries
India
Outcome results
None listed