A Randomized Controled Trial of Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia Storm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring
研究概览
简要总结
Ventricular Tachycardia storm is a medical emergency characterized by three or more episodes of ventricular arrhythmia within 24 hours and associated with a significantly increased mortality and massive health resource utilization. Several therapies are utilized including sympathetic blockade (through deep sedation and beta blockers), antiarrhythmic drugs, implantable cardioverter defibrillator (ICD) reprograming where applicable, and catheter ablation. Despite standard intervention, mortality rates remain high and additional therapeutic options are actively being investigated.
The overall objective of this proposal is to investigate whether transcutaneous magnetic stimulation designed to inhibit the left stellate ganglion can be used in this population. This is a single-center, randomized, sham-controlled trial to assess the efficacy of transcutaneous magnetic stimulation of the left stellate ganglion to treat patients with ventricular tachycardia storm.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 3 episodes of VT in 24 hours
排除标准
- •Pregnancy
- •Implanted ventricular assist device
- •Metal implanted in head or neck (except the mouth)
- •Implanted medication pumps
- •Cochlear implant
- •Implanted brain stimulator
- •Ocular implant
- •History of active malignancy in region of stimulation (neck)
结局指标
主要结局
Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring
时间窗: 24-hours following completion of the protocol
Incidence of ventricular tachycardia on inpatient telemetry monitoring
次要结局
- Number of Patients With Changes in ICD or Pacemaker Lead Impedances(Immediately following completion of the protocol)
- Number of Patients With Changes in ICD or Pacemaker Lead Thresholds(Immediately following completion of the protocol)
- Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record(24 hours following completion of the protocol)
- Number of Patients With Changes in ECG Parameters(Immediately following completion of the stimulation)
- Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry(48-hours following completion of the protocol)
- Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities(Immediately following completion of the protocol)
- Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10)(Immediately following completion of the protocol)
- Number of Patients With Changes in Vital Signs(Immediately following the completion of the stimulation)