Percutaneous Blockade Protocol of the Stellate Ganglion in Patients With Refractory Electrical Storm

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Clinical Research Center of the Heart Institute - University of São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Alberto P Ferraz, MD
albertopferraz@gmail.com
+5511981043839
Time Frame
Start Date: 2025-06-06
Estimated Completion Date: 2028-12
Participants
Target number of participants: 64
Treatments
Active_comparator: Stellate Ganglion Block
No_intervention: Standard Treatment
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo General Hospital

This content was sourced from clinicaltrials.gov