A Phase 3 interventional study of Left ganglion stellate block and Sham left ganglion stellate block in Ventricular Arrythmia, Ventricular Tachycardia and Ventricular Fibrillation, sponsored by Institute for Clinical and Experimental Medicine. Status unknown at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Institute for Clinical and Experimental Medicine · Phase 3, Interventional, and Treatment
This study will evaluate the acute effect of ultrasound-navigated left ganglion stellate block to suppress ventricular arrhythmia in patients with arrhythmic storm.
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
This study's planned enrollment of 80 is above the median of 64 across 379 interventional studies indexed under Tachycardia.
Browse Tachycardia studies →Institute for Clinical and Experimental Medicine is the lead sponsor of 60 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
arrhythmic storm \<24 hours before inclusion:
Exclusion Criteria:
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
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
Ultrasound-guided anesthetic block of left ganglion stellate using 8ml of 5% bupivacaine.
Subcutaneous application of 0.5-1ml of 5% bupivacaine to the site of expected LGSB
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)
Plan to share: Undecided
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This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Institute for Clinical and Experimental Medicine