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临床试验/NCT02646501
NCT02646501Unknown不适用

Prospective Randomized Clinical Trial for Effect of Stellate Ganglion Block in Medically Refractory Ventricular Tachycardia

Yonsei University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Duration of VT/VF episodes after randomization

研究概览

简要总结

The investigators will compare the effects of PSGB(percutaneous stellate ganglion block) in patients with recurrent sustained VT/VF in spite of appropriate medical therapy and cardio-version/ defibrillation after correction of underlying correctable factors with those without PSGB by prospective randomized trail. PSGB will be performed every 3 days by anesthesiology specialist after cardiologist's request, until the stabilization of VT/VF. We will compare the frequency and episode number of VT/VF, procedure related complication, acute and long-term mortality.

详细描述

Recurrent ventricular tachycardia(VT)/ fibrillation(VF) increases mortality, especially in patients with structural heart disease. It has been reported that cardiac sympathectomy reduces VT/VF episodes in patients with complex VT, long QT syndrome, catecholaminergic polymorphic VT, or myocarditis. However, cardiac sympathectomy operation is hard to conduct in patients with hemodynamically unstable recurrent VT/VF or electrical storm. Therefore, we hypothesized that bed-side percutaneous stellate ganglion block (PSGB) reduces VT/VF episodes and mortality in patients with repetitive VT/VF who are properly managed with optimal medical therapies.

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
None

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients agreement of consent
  • AF patient age 20-85
  • Patient are diagnosed Refractory Ventricular tachycardia
  • Patients who have generated Refractory Ventricular tachycardia despite of defibrillation and drug therapy
  • Patients with ICD have generated ICD shock or anti-tachycardia pacing despite of defibrillation and drug therapy

排除标准

  • Patients who do not agree with study inclusion
  • Patients who do not taken stellate ganglion block due to unstable hemodynamic status
  • Patients have experienced major hemorrhagic complication
  • Patients of the DNR status
  • Patients with malignancy tumor, major neurogenic disease or gastrointestinal disease

研究组 & 干预措施

group A+PSGB

Experimental

(Antiarrhythmic drug + percutaneous stellate ganglion block) group

干预措施: Antiarrhythmic drug (Drug)

group A+PSGB

Experimental

(Antiarrhythmic drug + percutaneous stellate ganglion block) group

干预措施: percutaneous stellate ganglion block (PSGB) (Procedure)

group A

Active Comparator

Antiarrhythmic drug group

干预措施: Antiarrhythmic drug (Drug)

结局指标

主要结局

Duration of VT/VF episodes after randomization

时间窗: 5 days after randomization

Number of VT/VF episodes after randomization

时间窗: 5 days after randomization

次要结局

  • mortality(1 month after the enrollment)
  • procedure related complication(1 month after the enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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