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

• Sponsor: Institute for Clinical and Experimental Medicine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05078684
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 41.4
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Arrythmia; Ventricular Tachycardia; Ventricular Fibrillation; Arrhythmic Storm; Block	Procedure: Left ganglion stellate block; Procedure: Sham left ganglion stellate block	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomization 1:1 for active treatment vs. sham procedureRandomization 1:1 for active treatment vs. sham procedure
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Ganglion Stellate Block for Treatment of Electric Storm - a Randomized Study
• Actual Study Start Date: Aug 21, 2021
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Jan 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in the number of episodes of sustained VT/VF [2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)]

   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. Change in arrhythmia burden quantified by Holter ECG [2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Clinical and Experimental Medicine (IKEM)	Prague		Czechia	14059

Sponsors and Collaborators

• Institute for Clinical and Experimental Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marek Sramko, MD, PhD, Head of the Department of Acute Cardiology, Institute for Clinical and Experimental Medicine
• ClinicalTrials.gov Identifier: NCT05078684
• Other Study ID Numbers: A-21-25
• First Posted: Oct 14, 2021
• Last Update Posted: Oct 19, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular; Ventricular Fibrillation

Study Results

No Results Posted as of Oct 19, 2021