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

Ventricular Tachycardia Clinical Trial

— GANGSTER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078684
• Other study ID #: A-21-25
• Status: Recruiting
• Phase: Phase 3
• Start date: August 21, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: October 2021
• Source: Institute for Clinical and Experimental Medicine
• Contact: Marek Sramko, MD, PhD
• Phone: +420776246127
• Email: marek.sramko[@]ikem.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Block
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Arrythmia
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Procedure:
• Left ganglion stellate block
Ultrasound-guided anesthetic block of left ganglion stellate using 8ml of 5% bupivacaine.
• Sham left ganglion stellate block
Subcutaneous application of 0.5-1ml of 5% bupivacaine to the site of expected LGSB

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine (IKEM)	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)