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

NCT05078684 | Unknown Phase 3

• 1 other identifier: A-21-25
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Arrythmia; Ventricular Tachycardia; Ventricular Fibrillation; Arrhythmic Storm; Block

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Actual LGSB

ACTIVE COMPARATOR

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

Sham procedure

SHAM COMPARATOR

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

Interventions

Left ganglion stellate block PROCEDURE

Ultrasound-guided anesthetic block of left ganglion stellate using 8ml of 5% bupivacaine.

Actual LGSB

Sham left ganglion stellate block PROCEDURE

Subcutaneous application of 0.5-1ml of 5% bupivacaine to the site of expected LGSB

Sham procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 14059, Czechia

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation; Bites and Stings

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Central Study Contacts

Marek Sramko, MD, PhD

CONTACT

+420776246127; marek.sramko@ikem.cz

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Acute Cardiology

Model Details: Randomization 1:1 for active treatment vs. sham procedure

Study Record Dates

• First Submitted: August 21, 2021
• First Posted: October 14, 2021
• Study Start: August 21, 2021
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

CZ (1)