NCT02646501

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
3.2 years until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

January 4, 2016

Last Update Submit

February 7, 2019

Conditions

Refractory Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

  • Number of VT/VF episodes after randomization

    5 days after randomization

  • Duration of VT/VF episodes after randomization

    5 days after randomization

Secondary Outcomes (2)

  • mortality

    1 month after the enrollment

  • procedure related complication

    1 month after the enrollment

Study Arms (2)

group A+PSGB

EXPERIMENTAL

(Antiarrhythmic drug + percutaneous stellate ganglion block) group

Drug: Antiarrhythmic drugProcedure: percutaneous stellate ganglion block (PSGB)

group A

ACTIVE COMPARATOR

Antiarrhythmic drug group

Drug: Antiarrhythmic drug

Interventions

Antiarrhythmic drugDRUG

Antiarrhythmic drug

group Agroup A+PSGB
percutaneous stellate ganglion block (PSGB)PROCEDURE

percutaneous stellate ganglion block (PSGB)

group A+PSGB

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Anti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Hui-Nam Park, MD, Ph.D

CONTACT

82-2-2228-8459hnpak@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 5, 2016

Study Start

March 1, 2019

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

February 11, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)