Status:
COMPLETED
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study
Lead Sponsor:
Cyberonics, Inc.
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 fail...
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 ti...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with reduced EF and dilated hearts
Exclusion
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01823887
Start Date
July 1 2012
End Date
June 1 2014
Last Update
February 19 2015
Active Locations (1)
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1
Chennai, India