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

Ganglion Stellate Block for Treatment of Electric Storm - a Randomized Study

This study will evaluate the acute effect of ultrasound-navigated left ganglion stellate block to suppress ventricular arrhythmia in patients with arrhythmic storm.

Study Overview

• Status: Recruiting
• Conditions: Ventricular Fibrillation; Ventricular Tachycardia; Ventricular Arrythmia; Block; Arrhythmic Storm
• Intervention / Treatment: Procedure: Left ganglion stellate block; Procedure: Sham left ganglion stellate block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 14059
    • Recruiting
    • Institute for Clinical and Experimental Medicine (IKEM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Actual LGSB; 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.	Procedure: Left ganglion stellate block; Ultrasound-guided anesthetic block of left ganglion stellate using 8ml of 5% bupivacaine.
SHAM_COMPARATOR: Sham procedure; 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.	Procedure: Sham left ganglion stellate block; Subcutaneous application of 0.5-1ml of 5% bupivacaine to the site of expected LGSB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)
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).	2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)

Collaborators and Investigators

• Sponsor: Institute for Clinical and Experimental Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 21, 2021
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): January 31, 2025

Study Registration Dates

• First Submitted: August 21, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (ACTUAL): October 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: A-21-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No