Trials / Completed
CompletedNCT03163030
Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure With Preserved Ejection Fraction (ANTHEM-HFpEF) Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Cyberonics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The ANTHEM-HFpEF 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 with preserved and mid-range ejection fraction.
Detailed description
Heart failure patients will be enrolled and implanted with a cervical VNS system on the right side. After a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 12 months, with data collection at 3, 6, 9, and 12 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vagus Nerve Stimulation (VNS) | Electrical Stimulation of the Vagus Nerve |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2019-12-01
- Completion
- 2021-12-01
- First posted
- 2017-05-22
- Last updated
- 2023-05-06
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT03163030. Inclusion in this directory is not an endorsement.