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

February 17, 2015 updated by: Cyberonics, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Left Sided Stimulation
Left cervical Vagus Nerve Stimulation (VNS)
Device: Vagus Nerve Stimulation (VNS)
Electrical Stimulation of the Vagus Nerve
Experimental: Right Sided Stimulation
Right Cervical Vagus Nerve Stimulation (VNS)
Device: Vagus Nerve Stimulation (VNS)
Electrical Stimulation of the Vagus Nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Function
Time Frame: 6 months
Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)
6 months
Adverse Events
Time Frame: 6 months
Incidence of procedure and device-related complications
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Status
Time Frame: 6 months
6-minute walk test
6 months
Quality of Life
Time Frame: 6 months
Minnesota Living with Heart Failure Questionnaire
6 months
Functional Status
Time Frame: 6 months
New York Heart Association Class
6 months
Autonomic Function
Time Frame: 6 months
Heart Rate Variability (HRV)
6 months
Blood Biomarkers
Time Frame: 6 months
Blood Levels of Heart Failure Biomarkers
6 months
Cardiac Function
Time Frame: 6 months
Left ventricular end-systolic diameter (LVESD)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyberonics, Inc.

Investigators

  • Study Director: Imad Libbus, PhD, Cyberonics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 1, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 17, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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