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

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ClinicalTrials.gov Identifier: NCT02646501
Recruitment Status : Not yet recruiting
First Posted : January 5, 2016
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Refractory Ventricular Tachycardia Drug: Antiarrhythmic drug Procedure: percutaneous stellate ganglion block (PSGB) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Trial for Effect of Stellate Ganglion Block in Medically Refractory Ventricular Tachycardia
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of VT/VF episodes after randomization [ Time Frame: 5 days after randomization ]
  2. Duration of VT/VF episodes after randomization [ Time Frame: 5 days after randomization ]

Secondary Outcome Measures :
  1. mortality [ Time Frame: 1 month after the enrollment ]
    death, cause of death,

  2. procedure related complication [ Time Frame: 1 month after the enrollment ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646501


Contacts
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Contact: Hui-Nam Park, MD, Ph.D 82-2-2228-8459 hnpak@yuhs.ac

Locations
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Korea, Republic of
Severance Cardiovascular Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hui-Nam Pak, M.D., Ph.D.    82-2-2228-8459    hnpak@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02646501     History of Changes
Other Study ID Numbers: 4-2015-0743
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Anti-Arrhythmia Agents