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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left Sided Stimulation | Experimental | Left cervical Vagus Nerve Stimulation (VNS) |
|
| Right Sided Stimulation | Experimental | Right Cervical Vagus Nerve Stimulation (VNS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus Nerve Stimulation (VNS) | Device | Electrical Stimulation of the Vagus Nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Function | Left ventricular end-systolic volume (LVESV) and ejection fraction (EF) | 6 months |
| Adverse Events | Incidence of procedure and device-related complications | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Status | 6-minute walk test | 6 months |
| Quality of Life | Minnesota Living with Heart Failure Questionnaire | 6 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imad Libbus, PhD | Cyberonics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chennai | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24054343 | Background | Dicarlo L, Libbus I, Amurthur B, Kenknight BH, Anand IS. Autonomic regulation therapy for the improvement of left ventricular function and heart failure symptoms: the ANTHEM-HF study. J Card Fail. 2013 Sep;19(9):655-60. doi: 10.1016/j.cardfail.2013.07.002. | |
| 25187002 | Result | Premchand RK, Sharma K, Mittal S, Monteiro R, Dixit S, Libbus I, DiCarlo LA, Ardell JL, Rector TS, Amurthur B, KenKnight BH, Anand IS. Autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure: results of the ANTHEM-HF trial. J Card Fail. 2014 Nov;20(11):808-16. doi: 10.1016/j.cardfail.2014.08.009. Epub 2014 Sep 1. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| Functional Status | New York Heart Association Class | 6 months |
| Autonomic Function | Heart Rate Variability (HRV) | 6 months |
| Blood Biomarkers | Blood Levels of Heart Failure Biomarkers | 6 months |
| Cardiac Function | Left ventricular end-systolic diameter (LVESD) | 6 months |
| 35360224 | Derived | Libbus I, Premchand RK, Sharma K, Mittal S, Monteiro R, Amurthur B, KenKnight BH, DiCarlo LA, Anand IS. Persistent Autonomic Engagement and Cardiac Control After Four or More Years of Autonomic Regulation Therapy Using Vagus Nerve Stimulation. Front Physiol. 2022 Mar 11;13:853617. doi: 10.3389/fphys.2022.853617. eCollection 2022. |
| 33590355 | Derived | Nearing BD, Libbus I, Carlson GM, Amurthur B, KenKnight BH, Verrier RL. Chronic vagus nerve stimulation is associated with multi-year improvement in intrinsic heart rate recovery and left ventricular ejection fraction in ANTHEM-HF. Clin Auton Res. 2021 Jun;31(3):453-462. doi: 10.1007/s10286-021-00780-y. Epub 2021 Feb 16. |
| 27221316 | Derived | Nearing BD, Libbus I, Amurthur B, Kenknight BH, Verrier RL. Acute Autonomic Engagement Assessed by Heart Rate Dynamics During Vagus Nerve Stimulation in Patients With Heart Failure in the ANTHEM-HF Trial. J Cardiovasc Electrophysiol. 2016 Sep;27(9):1072-7. doi: 10.1111/jce.13017. Epub 2016 Jul 7. |
| 26601770 | Derived | Libbus I, Nearing BD, Amurthur B, KenKnight BH, Verrier RL. Autonomic regulation therapy suppresses quantitative T-wave alternans and improves baroreflex sensitivity in patients with heart failure enrolled in the ANTHEM-HF study. Heart Rhythm. 2016 Mar;13(3):721-8. doi: 10.1016/j.hrthm.2015.11.030. Epub 2015 Nov 18. |