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GANGlion Stellate Block for Treatment of Electric storRm (GANGSTER Trial) (GANGSTER)

Primary Purpose

Ventricular Arrythmia, Ventricular Tachycardia, Ventricular Fibrillation

Status
Recruiting
Phase
Phase 3
Locations
Czechia
Study Type
Interventional
Intervention
Left ganglion stellate block
Sham left ganglion stellate block
Sponsored by
Institute for Clinical and Experimental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Arrythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. arrhythmic storm <24 hours before inclusion:

    • 3 or more episodes of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) terminated by external or internal shock,
    • or incessant VT lasting >30 minutes,
    • or very frequent nonsustained or sustained VT leading to hemodynamic instability with the need of escalation of the therapy
  2. clinical indication for LBGS based on the judgment of the physician, independent of the study

Exclusion Criteria:

  1. known allergy to bupivacaine
  2. prior LBGS performed <7 days before the study
  3. known reversible provoking trigger of the arrhythmias
  4. ventricular arrhythmias triggered by premature ectopic beats during bradycardia
  5. hemodynamically tolerated idiopathic VT in patients without structural heart disease

Sites / Locations

  • Institute for Clinical and Experimental Medicine (IKEM)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Actual LGSB

Sham procedure

Arm Description

The patients will receive an actual LGSB procedure: Using ultrasound navigation and an echo-contrast needle, 8ml of bupivacain (5%) will be applied to the site of the left ganglion stellate through an anterolateral approach in the neck region.

The procedure will be performed using the same instruments and anesthetic drug as the actual LGSB. However, the operator will apply only 0.5-1ml of the anesthetic drug and only subcutaneously to the site where an actual LGSB would be performed.

Outcomes

Primary Outcome Measures

Change in the number of episodes of sustained VT/VF
Change by >50% of the number of episodes of sustained ventricular tachycardia/fibrillation compared to 24 hours before LGSB, without escalation of antiarrhythmic therapy during 24 hours after LGSB (deep sedation requiring mechanical ventilation, addition of another antiarrhythmic drug, implantation of mechanical circulatory support, unplanned emergent catheter ablation)
Change in arrhythmia burden quantified by Holter ECG
Change of the percent of QRS complexes with ventricular tachycardia by >50% on Holter ECG, as compared to 24 hours before LGSB, without escalation of antiarrhythmic therapy during 24 hours after LGSB (deep sedation requiring mechanical ventilation, addition of another antiarrhythmic drug, implantation of mechanical circulatory support, unplanned emergent catheter ablation).

Secondary Outcome Measures

Full Information

First Posted
August 21, 2021
Last Updated
October 14, 2021
Sponsor
Institute for Clinical and Experimental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05078684
Brief Title
GANGlion Stellate Block for Treatment of Electric storRm (GANGSTER Trial)
Acronym
GANGSTER
Official Title
Ganglion Stellate Block for Treatment of Electric Storm - a Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for Clinical and Experimental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the acute effect of ultrasound-navigated left ganglion stellate block to suppress ventricular arrhythmia in patients with arrhythmic storm.
Detailed Description
The study will include patients with drug-refractory arrhythmic storm indicated for left ganglion stellate block (LGSB) before or after catheter ablation. Included participants will be dived based on the need for mechanical ventilation and catheter ablation performed <5 days before the study Subsequently, the participants will be randomized to LGSB or to a sham (placebo) procedure. The primary endpoint will be a reduction of the burden of clinical arrhythmia >50% 24 hours after LGSB without escalation of antiarrhythmic therapy. The study will include 80 patients over 4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrythmia, Ventricular Tachycardia, Ventricular Fibrillation, Arrhythmic Storm, Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomization 1:1 for active treatment vs. sham procedure
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Patients, attending staff, and outcome assessors will not know whether the patient received the actual LGSB or a sham (placebo) procedure. The sham procedure will consist of subcutaneous application of a small amount (1ml) of the local anesthetic drug to the region of expected LGSB procedure.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Actual LGSB
Arm Type
Active Comparator
Arm Description
The patients will receive an actual LGSB procedure: Using ultrasound navigation and an echo-contrast needle, 8ml of bupivacain (5%) will be applied to the site of the left ganglion stellate through an anterolateral approach in the neck region.
Arm Title
Sham procedure
Arm Type
Sham Comparator
Arm Description
The procedure will be performed using the same instruments and anesthetic drug as the actual LGSB. However, the operator will apply only 0.5-1ml of the anesthetic drug and only subcutaneously to the site where an actual LGSB would be performed.
Intervention Type
Procedure
Intervention Name(s)
Left ganglion stellate block
Intervention Description
Ultrasound-guided anesthetic block of left ganglion stellate using 8ml of 5% bupivacaine.
Intervention Type
Procedure
Intervention Name(s)
Sham left ganglion stellate block
Intervention Description
Subcutaneous application of 0.5-1ml of 5% bupivacaine to the site of expected LGSB
Primary Outcome Measure Information:
Title
Change in the number of episodes of sustained VT/VF
Description
Change by >50% of the number of episodes of sustained ventricular tachycardia/fibrillation compared to 24 hours before LGSB, without escalation of antiarrhythmic therapy during 24 hours after LGSB (deep sedation requiring mechanical ventilation, addition of another antiarrhythmic drug, implantation of mechanical circulatory support, unplanned emergent catheter ablation)
Time Frame
2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)
Title
Change in arrhythmia burden quantified by Holter ECG
Description
Change of the percent of QRS complexes with ventricular tachycardia by >50% on Holter ECG, as compared to 24 hours before LGSB, without escalation of antiarrhythmic therapy during 24 hours after LGSB (deep sedation requiring mechanical ventilation, addition of another antiarrhythmic drug, implantation of mechanical circulatory support, unplanned emergent catheter ablation).
Time Frame
2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: arrhythmic storm <24 hours before inclusion: 3 or more episodes of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) terminated by external or internal shock, or incessant VT lasting >30 minutes, or very frequent nonsustained or sustained VT leading to hemodynamic instability with the need of escalation of the therapy clinical indication for LBGS based on the judgment of the physician, independent of the study Exclusion Criteria: known allergy to bupivacaine prior LBGS performed <7 days before the study known reversible provoking trigger of the arrhythmias ventricular arrhythmias triggered by premature ectopic beats during bradycardia hemodynamically tolerated idiopathic VT in patients without structural heart disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marek Sramko, MD, PhD
Phone
+420776246127
Email
marek.sramko@ikem.cz
Facility Information:
Facility Name
Institute for Clinical and Experimental Medicine (IKEM)
City
Prague
ZIP/Postal Code
14059
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Sramko, MD, PhD
Phone
+420731682681
Email
marek.sramko@ikem.cz

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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GANGlion Stellate Block for Treatment of Electric storRm (GANGSTER Trial)

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