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

Primary Purpose

Refractory Ventricular Tachycardia

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Antiarrhythmic drug

percutaneous stellate ganglion block (PSGB)

About this trial

This is an interventional treatment trial for Refractory Ventricular Tachycardia

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Severance Cardiovascular Hospital, Yonsei University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group A+PSGB

group A

Arm Description

(Antiarrhythmic drug + percutaneous stellate ganglion block) group

Antiarrhythmic drug group

Outcomes

Primary Outcome Measures

Number of VT/VF episodes after randomization

Duration of VT/VF episodes after randomization

Secondary Outcome Measures

mortality

death, cause of death,

procedure related complication

Full Information

NCT ID

NCT02646501

First Posted

January 4, 2016

Last Updated

February 7, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02646501

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 2019 (Anticipated)

Primary Completion Date

September 2019 (Anticipated)

Study Completion Date

September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Ventricular Tachycardia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group A+PSGB

Arm Type

Experimental

Arm Description

(Antiarrhythmic drug + percutaneous stellate ganglion block) group

Arm Title

group A

Arm Type

Active Comparator

Arm Description

Antiarrhythmic drug group

Intervention Type

Drug

Intervention Name(s)

Antiarrhythmic drug

Intervention Description

Antiarrhythmic drug

Intervention Type

Procedure

Intervention Name(s)

percutaneous stellate ganglion block (PSGB)

Intervention Description

percutaneous stellate ganglion block (PSGB)

Primary Outcome Measure Information:

Title

Number of VT/VF episodes after randomization

Time Frame

5 days after randomization

Title

Duration of VT/VF episodes after randomization

Time Frame

5 days after randomization

Secondary Outcome Measure Information:

Title

mortality

Description

death, cause of death,

Time Frame

1 month after the enrollment

Title

procedure related complication

Time Frame

1 month after the enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hui-Nam Park, MD, Ph.D

Phone

82-2-2228-8459

hnpak@yuhs.ac

Facility Information:

Facility Name

Severance Cardiovascular Hospital, Yonsei University Health System

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

Phone

82-2-2228-8459

hnpak@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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