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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01823887
First Posted: April 4, 2013
Last Update Posted: February 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cyberonics, Inc.
April 1, 2013
April 4, 2013
February 19, 2015
July 2012
April 2014   (Final data collection date for primary outcome measure)
  • Cardiac Function [ Time Frame: 6 months ]
    Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)
  • Adverse Events [ Time Frame: 6 months ]
    Incidence of procedure and device-related complications
  • Cardiac Function [ Time Frame: 6 months ]
    Composite of left ventricular end-systolic volume (LVESV), left ventricular end-systolic diameter (LVESD), and ejection fraction (EF)
  • Adverse Events [ Time Frame: 6 months ]
    Incidence of procedure and device-related complications
Complete list of historical versions of study NCT01823887 on ClinicalTrials.gov Archive Site
  • Functional Status [ Time Frame: 6 months ]
    6-minute walk test
  • Quality of Life [ Time Frame: 6 months ]
    Minnesota Living with Heart Failure Questionnaire
  • Functional Status [ Time Frame: 6 months ]
    New York Heart Association Class
  • Autonomic Function [ Time Frame: 6 months ]
    Heart Rate Variability (HRV)
  • Blood Biomarkers [ Time Frame: 6 months ]
    Blood Levels of Heart Failure Biomarkers
  • Cardiac Function [ Time Frame: 6 months ]
    Left ventricular end-systolic diameter (LVESD)
  • Functional Status [ Time Frame: 6 months ]
    6-minute walk test
  • Quality of Life [ Time Frame: 6 months ]
    Minnesota Living with Heart Failure Questionnaire
  • Functional Status [ Time Frame: 6 months ]
    New York Heart Association Class
  • Autonomic Function [ Time Frame: 6 months ]
    Heart Rate Variability (HRV)
  • Blood Biomarkers [ Time Frame: 6 months ]
    Blood Levels of Heart Failure Biomarkers
Not Provided
Not Provided
 
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Congestive Heart Failure
Device: Vagus Nerve Stimulation (VNS)
Electrical Stimulation of the Vagus Nerve
  • Experimental: Left Sided Stimulation
    Left cervical Vagus Nerve Stimulation (VNS)
    Intervention: Device: Vagus Nerve Stimulation (VNS)
  • Experimental: Right Sided Stimulation
    Right Cervical Vagus Nerve Stimulation (VNS)
    Intervention: Device: Vagus Nerve Stimulation (VNS)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with reduced EF and dilated hearts
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01823887
C-01
Yes
Not Provided
Not Provided
Cyberonics, Inc.
Cyberonics, Inc.
Not Provided
Study Director: Imad Libbus, PhD Cyberonics, Inc.
Cyberonics, Inc.
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP