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

Institute for Clinical and Experimental Medicine

Status and phase: Enrolling; Phase 3

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

Treatments: Procedure: Sham left ganglion stellate block; Procedure: Left ganglion stellate block

Study type: Interventional

Funder types: Other

Identifiers

NCT05078684

A-21-25

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Actual LGSB

Active Comparator group

Description:

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.

Treatment:

Procedure: Left ganglion stellate block

Sham procedure

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham left ganglion stellate block