About this trial
There is no randomized clinical study in the literature that evaluated the efficacy and safety of the stellate ganglion infiltration procedure in patients with electrical storm. So far, case reports and retrospective studies suggest that such a strategy should be considered in cases refractory to initial therapy. In this scenario, the European and American guidelines for the treatment of ventricular arrhythmias recommend autonomic modulation in this setting, but only with a level of recommendation IIb (1,2). This project aims to evaluate the effect of stellate ganglion infiltration in patients with electric storm refractory to initial clinical measures. It is a randomized clinical trial where patients will receive treatment with a lidocaine and bupivacaine anesthetic solution or no intervention. The effect of the intervention will be considered positive when there is a reduction of arrhythmic events of at least 50% in the 12 hours immediately after.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years old with structural heart disease and a diagnosis of refractory electrical storm, or those who require discontinuation of antiarrhythmics due to adverse events or contraindications to standard therapy.
Disqualifiers
Patients under 18
History of heart transplant or prior cardiac denervation surgery
Anatomical contraindications for the procedure (prior neck surgery, burns, large scars, or thyroid goiter).
Genetically related polymorphic VT
Trial design
Parallel
Treatments tested in this trial
Stellate Ganglion Block
Procedure/SurgeryThere is no randomized clinical study in the literature that evaluated the efficacy and safety of the stellate ganglion infiltration procedure in patients with electrical storm.
Treatment groups
Trial outcomes
Primary outcomes
Reduction in arrhythmic events
A ≥50% reduction in arrhythmic events (VT/VF)
Secondary outcomes
ICD therapies
Reduction in the number of ATPs/ICD shocks
Urgent ablation and other invasive therapies
urgent ablation and other invasive therapies (e.g., intra-aortic balloon pump placement or intubation for deep sedation)
Sponsors and contacts
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