Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions.
研究概览
简要总结
Prospective randomized control pilot study
详细描述
The primary aims of this investigator initiated study is :
Aim 1: to assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions and Aim 2: to compare the efficacy of Lower-level Tragus stimulation and Heart rate variability- Biofeedback in suppression of Premature Ventricular Contractions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Normal Left Ventricular systolic function
- •Frequent PVCs
排除标准
- •Current use of any (I and/or III) antiarrhythmic medication
- •Contraindication to use beta blockers and non-dihydropyridine calcium channel blockers
- •Complete Atrioventricular block and pacemaker dependent
- •Ongoing uncontrolled hypertension with systolic Blood Pressure> 180
- •Family history of dilated Cardiomyopathy in a first degree relative
- •Alcohol use disorder or illicit drug use
- •Actively being treated Atrial fibrillation/ Flutter with Rapid Ventricular Response
- •Moderate to severe valve disorders
- •Patient with shortwave/microwave therapy equipment
结局指标
主要结局
Assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions.
时间窗: perspective 12-week study (each arm lasting two weeks with a one week washout between each arm)
Compare the effects of Premature Ventricular Contractions suppression between standard medical therapy and non-invasive vagal nerve stimulation.
次要结局
- Compare the efficacy of non-invasive vagal nerve stimulation via lower-level vagal stimulation and heart rate variability in suppression of Premature Ventricular Contractions.(perspective 12-week study (each arm lasting two weeks with a one-week washout between each arm))
研究者
Jose Huizar
Associate Chief of Staff for Research and Development at VAMC, Professor of Medicine at VCU, Director, Arrhythmia and Device Clinic at VAMC and Affiliate Professor of Physiology and Biophysics VCU
Hunter Holmes Mcguire Veteran Affairs Medical Center