Trials / Completed
CompletedNCT01823887
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Cyberonics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vagus Nerve Stimulation (VNS) | Electrical Stimulation of the Vagus Nerve |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2014-04-01
- Completion
- 2014-06-01
- First posted
- 2013-04-04
- Last updated
- 2015-02-19
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT01823887. Inclusion in this directory is not an endorsement.