Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study (VNS-EPS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Sinus Cycle Length
研究概览
简要总结
The Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study is a single center, pilot, prospective study that aims at evaluating the effects of auricular vagus nerve stimulation (aVNS) on the human cardiac conduction system.
详细描述
The Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study is a single center, pilot, prospective study that aims at evaluating the effects of auricular vagus nerve stimulation (aVNS) on the human cardiac conduction system. In this study, we will enroll 10 healthy individuals presenting to the electrophysiology laboratory for an electrophysiological study (EPS). Patients will undergo a standard EPS with 4 catheters (coronary sinus catheter, His catheter, right ventricular catheter, and right atrial catheter). Following the standard EPS, patients will be hooked up a Parasym device to provide transcutaneous electrical stimulation to the auricular branch of the vagus nerve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Primary indication for EPS for the evaluation of cardiac conduction system or supraventricular tachycardia.
排除标准
- •Previous EPS with ablation
- •Previous failed ablation
- •Known conduction system disease, right or left bundle branch block on EKG
- •Pregnant women
- •History of postural orthostatic tachycardia syndrome
- •Patients who have had prior cervical vagotomy
- •Patients with skin on the tragus that is broken or cracked
- •Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years) and patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
- •Patients with an active implantable medical device, such as a cardiac pacemaker, hearing aid implant, or any implanted metallic, implanted vagus nerve stimulator or electronic device.
研究组 & 干预措施
Auricular Vagal Nerve Stimulation
Patients will undergo a standard EPS with 4 catheters. Following the standard EPS, patients will be hooked up a Parasym device to provide transcutaneous electrical stimulation to the auricular branch of the vagus nerve, EPS will be repeated.
干预措施: Auricular Vagal Nerve Stimulation (Device)
结局指标
主要结局
Change in Sinus Cycle Length
时间窗: Pre procedure/procedure
Sinus cycle length (msec)
Change in QRS Duration
时间窗: Pre procedure/procedure
QRS Duration (msec)
Change in AV Node Wenckebach Cycle Length
时间窗: Pre procedure/procedure
AV Node Wenckebach Cycle Length (msec)
Change in AV Node Effective Refractory Period
时间窗: Pre procedure/procedure
AV Node Effective Refractory Period (ERP) (msec)
Change in Right Ventricular Effective Refractory Period ERP
时间窗: Pre procedure/procedure
Right Ventricular Effective Refractory Period ERP (msec)
Supraventricular Tachycardia induction
时间窗: Pre procedure/procedure
Supraventricular Tachycardia induction
Change in A-H Interval
时间窗: Pre procedure/procedure
A-H Interval (msec)
Change in H-V Interval
时间窗: Pre procedure/procedure
H-V interval (msec)
Change in Atrial Effective Refractory Period
时间窗: Pre procedure/procedure
Atrial Effective Refractory Period ERP (msec)
Change in Accessory Pathway Anterograde Effective Refractory Period ERP
时间窗: Pre procedure/procedure
Accessory Pathway Anterograde Effective Refractory Period (msec)
Change in QT Duration
时间窗: Pre procedure/procedure
QT Duration (msec)
Change in Sinus Node Recovery Time
时间窗: Pre procedure/procedure
Sinus Node Recovery Time (msec)
Change in Accessory Pathway Retrograde Effective Refractory Period ERP
时间窗: Pre procedure/procedure
Accessory Pathway Anterograde Effective Refractory Period (msec)
Change in retrograde block cycle length
时间窗: Pre procedure/procedure
Retrograde Block Cycle Length (msec)
Supraventricular Tachycardia Termination
时间窗: Pre procedure/procedure
Supraventricular Tachycardia Termination
次要结局
未报告次要终点