Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study

Phase 1

Completed

• Conditions: Congestive Heart Failure
• Interventions: Device: Vagus Nerve Stimulation (VNS)

• Registration Number: NCT01823887
• Lead Sponsor: Cyberonics, Inc.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-04
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-17
• Last Update Posted: 2015-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with reduced EF and dilated hearts

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Right Sided Stimulation	Vagus Nerve Stimulation (VNS)	Right Cervical Vagus Nerve Stimulation (VNS)
Left Sided Stimulation	Vagus Nerve Stimulation (VNS)	Left cervical Vagus Nerve Stimulation (VNS)

Primary Outcome Measures

Name	Time	Method
Cardiac Function	6 months	Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)
Adverse Events	6 months	Incidence of procedure and device-related complications

Secondary Outcome Measures

Name	Time	Method
Blood Biomarkers	6 months	Blood Levels of Heart Failure Biomarkers
Autonomic Function	6 months	Heart Rate Variability (HRV)
Quality of Life	6 months	Minnesota Living with Heart Failure Questionnaire
Cardiac Function	6 months	Left ventricular end-systolic diameter (LVESD)
Functional Status	6 months	New York Heart Association Class