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

Institute for Clinical and Experimental Medicine80 enrolled

Overview

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

* 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Ventricular Arrythmia Ventricular Tachycardia Ventricular Fibrillation Arrhythmic Storm Block

Interventions

Left ganglion stellate blockPROCEDURE

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

Sham left ganglion stellate blockPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute for Clinical and Experimental Medicine (IKEM)

Prague, Czechia

RECRUITING

Outcomes

Primary Outcomes

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)

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)

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).

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)

Central Contacts

Marek Sramko, MD, PhD

CONTACT

+420776246127 marek.sramko@ikem.cz

Data from ClinicalTrials.gov

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