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

NCT ID: NCT02646501

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-31
• Study Completion Date: 2019-09-30

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.

Conditions

Refractory Ventricular Tachycardia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group A+PSGB

(Antiarrhythmic drug + percutaneous stellate ganglion block) group

Group Type: EXPERIMENTAL

Antiarrhythmic drug

Intervention Type: DRUG

Antiarrhythmic drug

percutaneous stellate ganglion block (PSGB)

Intervention Type: PROCEDURE

percutaneous stellate ganglion block (PSGB)

group A

Antiarrhythmic drug group

Group Type: ACTIVE_COMPARATOR

Antiarrhythmic drug

Intervention Type: DRUG

Antiarrhythmic drug

Interventions

Antiarrhythmic drug

Antiarrhythmic drug

Intervention Type: DRUG

percutaneous stellate ganglion block (PSGB)

percutaneous stellate ganglion block (PSGB)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, , South Korea

Countries

South Korea

Central Contacts

Hui-Nam Park, MD, Ph.D

Role: CONTACT

hnpak@yuhs.ac

82-2-2228-8459

Facility Contacts

Hui-Nam Pak, M.D., Ph.D.

Role: primary

hnpak@yuhs.ac

82-2-2228-8459

Other Identifiers

4-2015-0743

Identifier Type: -

Identifier Source: org_study_id