NCT01823887已完成1 期
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cardiac Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with reduced EF and dilated hearts
排除标准
- 未提供
结局指标
主要结局
Cardiac Function
时间窗: 6 months
Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)
Adverse Events
时间窗: 6 months
Incidence of procedure and device-related complications
次要结局
- Autonomic Function(6 months)
- Quality of Life(6 months)
- Blood Biomarkers(6 months)
- Cardiac Function(6 months)
- Functional Status(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Autonomic Regulation Therapy in Heart Failure With Preserved Ejection FractionCongestive Heart FailureNCT03163030Cyberonics, Inc.52
进行中（未招募）
不适用
A study to determine if therapeutic vagal nerve stimulation could improve functioning of the heart in diastolic heart failure patients.CTRI/2014/08/004851ivaNova PLC
招募中
不适用
Autonomic Regulation Therapy for treatment of Heart Failure.CTRI/2012/05/002681Cyberonics Inc60
已完成
不适用
Personalized Therapeutic Neuromodulation for Anhedonic DepressionTreatment Resistant DepressionNCT05144789Stanford University70
撤回
不适用
Vagus Nerve Stimulator for Autism and Other Developmental DisordersAutonomic Nervous SystemDevelopmental DisabilityAutism Spectrum DisorderIntellectual DisabilityNCT06259201New York State Institute for Basic Research75