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

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.

Study Overview

• Status: Unknown
• Conditions: Refractory Ventricular Tachycardia
• Intervention / Treatment: Drug: Antiarrhythmic drug; Procedure: percutaneous stellate ganglion block (PSGB)

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui-Nam Park, MD, Ph.D; Phone Number: 82-2-2228-8459; Email: hnpak@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Cardiovascular Hospital, Yonsei University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A+PSGB; (Antiarrhythmic drug + percutaneous stellate ganglion block) group	Drug: Antiarrhythmic drug; Antiarrhythmic drug; Procedure: percutaneous stellate ganglion block (PSGB); percutaneous stellate ganglion block (PSGB)
Active Comparator: group A; Antiarrhythmic drug group	Drug: Antiarrhythmic drug; Antiarrhythmic drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular; Anti-Arrhythmia Agents
• Other Study ID Numbers: 4-2015-0743

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No