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

Not Applicable

• Conditions: Refractory Ventricular Tachycardia
• Interventions: Drug: Antiarrhythmic drug; Procedure: percutaneous stellate ganglion block (PSGB)

• Registration Number: NCT02646501
• Lead Sponsor: Yonsei University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-11
• Study Start: 2019-03
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A+PSGB	Antiarrhythmic drug	(Antiarrhythmic drug + percutaneous stellate ganglion block) group
group A+PSGB	percutaneous stellate ganglion block (PSGB)	(Antiarrhythmic drug + percutaneous stellate ganglion block) group
group A	Antiarrhythmic drug	Antiarrhythmic drug group

Primary Outcome Measures

Name	Time	Method
Duration of VT/VF episodes after randomization	5 days after randomization
Number of VT/VF episodes after randomization	5 days after randomization

Secondary Outcome Measures

Name	Time	Method
mortality	1 month after the enrollment	death, cause of death,
procedure related complication	1 month after the enrollment

Trial Locations

Locations (1)

Severance Cardiovascular Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of