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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Refractory Ventricular Tachycardia

Intervention / Treatment
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* Drug: Antiarrhythmic drug
* Procedure: percutaneous stellate ganglion block (PSGB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A+PSGB<br>(Antiarrhythmic drug + percutaneous stellate ganglion block) group | Drug: Antiarrhythmic drug<br>* Antiarrhythmic drug<br>Procedure: percutaneous stellate ganglion block (PSGB)<br>* percutaneous stellate ganglion block (PSGB)<br>|
| Active Comparator: group A<br>Antiarrhythmic drug group | Drug: Antiarrhythmic drug<br>* Antiarrhythmic drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of VT/VF episodes after randomization |  | 5 days after randomization | 
| Duration of VT/VF episodes after randomization |  | 5 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | death, cause of death, | 1 month after the enrollment | 
| procedure related complication |  | 1 month after the enrollment |