NCT05078684

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Institute for Clinical and Experimental Medicine · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventricular Arrythmia
• Ventricular Tachycardia
• Ventricular Fibrillation
• Arrhythmic Storm
• Block

Interventions

Type	Name	Description
PROCEDURE	Left ganglion stellate block	Ultrasound-guided anesthetic block of left ganglion stellate using 8ml of 5% bupivacaine.
PROCEDURE	Sham left ganglion stellate block	Subcutaneous application of 0.5-1ml of 5% bupivacaine to the site of expected LGSB

Timeline

• Start date: 2021-08-21
• Primary completion: 2024-12-31
• Completion: 2025-01-31
• First posted: 2021-10-14
• Last updated: 2021-10-19

Locations

1 site across 1 country: Czechia