Randomized Assessment of the Efficacy of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- VT Burden (24 hours)
研究概览
简要总结
Three-arm randomized clinical trial comparing two strategies of TcMS to sham stimulation in patients with VT storm. The hypothesis of the study is that TcMS will reduce the burden of VT in the 24 hours after randomization compared to sham stimulation and that TcMS with theta burst stimulation (TBS) will be more effective at reducing VT burden than low frequency TcMS.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥3 episodes of sustained VT or appropriate ICD therapies within 24 hours despite the use of at least one antiarrhythmic drug
排除标准
- •Plan for catheter ablation of VT in the next 24 hours
- •Pregnancy
- •Contraindication to TcMS (i.e. implantable ventricular assist device, metal implanted in the head or neck [except the mouth], implanted medication pumps, cochlear implant, implanted brain stimulator, ocular implant, history of malignancy in the neck)
研究组 & 干预措施
Sham Stimulation
With the coil directed away from the patient, 600 pulses of TcMS will be delivered at minimal energy output.
干预措施: Magnetic Stimulation (Device)
Low Frequency TcMS
With the coil directed at the stellate ganglion, 60 minutes of 1Hz stimulation will be delivered targeting the stellate ganglion.
干预措施: Magnetic Stimulation (Device)
Theta Burst Stimulation TcMS
With the coil directed at the stellate ganglion, 600 pulses of continuous theta burst stimulation will be delivered targeting the stellate ganglion.
干预措施: Magnetic Stimulation (Device)
结局指标
主要结局
VT Burden (24 hours)
时间窗: 24 hours after randomization
Number of episodes of sustained ventricular tachycardia
次要结局
- Lead sensing(Immediately before and after stimulation)
- Blood Pressure(Immediately before and after stimulation)
- Heart Rate(Immediately before and after stimulation)
- Lead threshold(Immediately before and after stimulation)
- VT burden (72 hours)(72 hours after randomization)
- Freedom from VT(24 hours after randomization)
- Lead impedance(Immediately before and after stimulation)
- Pain(Immediately after stimulation)