A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing Ventricular Tachycardia (VT) Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- The change in ventricular action potential duration during stimulation compared to baseline in msec
研究概览
简要总结
Vagus nerve stimulation (VNS) has been shown to be beneficial in multiple studies including heart failure. The goal of this clinical investigation is to gain additional information about how vagus nerve stimulation relates to abnormal heart rhythms. The outcomes of this study will help researchers design new therapies for patients that have complex and life-threatening ventricular arrhythmias.
详细描述
This study is a non-randomized, prospective study in 6 patients with scar mediated ventricular arrhythmias who are scheduled to undergo a catheter ablation procedure. The study will last up to 30 minutes in the cardiac electrophysiology lab. Cervical VNS is performed percutaneously through the internal jugular vein during the patient's routine ventricular tachycardia (VT) ablation procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Presence of structural heart disease as defined as EF ≤ 50% or presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy.
- •Age > 18 years old
- •Underlying sinus rhythm with heart rate > 50 bpm.
- •Provision of signed/dated informed consent and stated willingness to comply with all study procedures
排除标准
- •Active ongoing cardiac ischemia as assessed by: ECG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (>70%), or stress testing. (Note: positive troponin assay due to Internal Cardiac Defibrillator (ICD) shocks is not an exclusion criterion).
- •Status post orthotopic heart transplantation
- •Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
- •Unable or unwilling to comply with protocol requirements.
- •Known channelopathy such as long QT syndrome, Brugada syndrome, and catecholaminergic polymorphic VT.
- •Known peripheral neuropathy or history of autonomic dysfunction due to non-cardiac causes.
- •New York Heart Association Class IV heart failure or use of current vasopressor medications
- •Incessant VT
- •Persistent atrial fibrillation
- •Frequent premature atrial or ventricular contractions
- •Inability to give informed consent.
结局指标
主要结局
The change in ventricular action potential duration during stimulation compared to baseline in msec
时间窗: Up to 30 minutes or completion of the vagus nerve stimulation
次要结局
- The change in blood pressure during stimulation compared to baseline in mmHg.(Up to 30 minutes or completion of the vagus nerve stimulation)
- The change in heart rate during stimulation compared to baseline in beats per minute(Up to 30 minutes or completion of the vagus nerve stimulation)
研究者
Kalyanam Shivkumar, MD, PhD
Director, UCLA Cardiac Arrhythmia Center & EP Programs
University of California, Los Angeles