Percutaneous Blockade of the Stellate Ganglion in Electrical Storm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stellate Ganglion Block.
- Who it may be relevant to
- Registry conditions: Electrical Storm, Stellate Ganglion Block, Ventricular Arrhythmia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Percutaneous Blockade Protocol of the Stellate Ganglion in Patients With Refractory Electrical Storm
Overview
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.
Detailed description
The study aims to evaluate the reduction of arrhythmic events following stellate ganglion blockade in patients with electrical storm refractory to initial clinical measures.
Hypothesis Stellate ganglion infiltration is an effective neuromodulation strategy for controlling arrhythmic events in patients with electrical storm awaiting definitive therapy.
Methodology This is a single-center randomized study investigating the efficacy of stellate ganglion blockade in patients with electrical storm refractory to initial clinical measures.
Participant Selection and Sample Size Participants will include patients admitted to the Emergency Unit or any Intensive Care Unit with a diagnosis of refractory electrical storm. Based on the STAR study, which reported a median of 6 arrhythmic events before SGB (IQR: 3 to 15.8), and aiming for at least a 50% reduction in arrhythmias in the active group post-procedure (with no expected change in the placebo group), a sample size of 32 patients per group was calculated (alpha = 0.05, power = 80%, two-tailed test).
Definitions Electrical storm (ES) is defined as three or more episodes of ventricular arrhythmias (including appropriate ICD therapies), separated by at least 5 minutes, within 24 hours. Refractory ES is defined as recurrent arrhythmias despite antiarrhythmic drug administration. Patients requiring discontinuation of antiarrhythmics due to adverse events will also be eligible for SGB. An arrhythmic event is defined as an episode of sustained VT or VF (\>30 seconds or unstable), treated or not with antitachycardia pacing (ATP), electrical therapy, ICD shock, or external defibrillation. Pre-specified complications include: simple hematoma, hematoma requiring intervention, symptoms due to anesthetic absorption, brachial plexus injury, simple vascular injury, and vascular injury requiring intervention.
Randomization Randomization will be performed by a medical professional not involved in the infiltration procedure and blinded to data analysis, using the "Randomizer for Clinical Trial" software.
Interventions
- Procedure Stellate Ganglion Block
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.
Primary outcome measures
- Reduction in arrhythmic events [Time frame: 12 hours immediately after the blockade compared to the 12 hours immediately before]
Secondary outcome measures (2)
- ICD therapies [Time frame: 12 hours immediately after stellate ganglion block (SGB) compared to the 12 hours immediately before]
- Urgent ablation and other invasive therapies [Time frame: 72 hours after the blockade]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
- End-stage renal disease on dialysis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Clinical Research Center of the Heart Institute - University of São Paulo — São Paulo
Publications
- Savastano S, Baldi E, Compagnoni S, Rordorf R, Sanzo A, Gentile FR, Dusi V, Frea S, Gravinese C, Cauti FM, Iannopollo G, De Sensi F, Gandolfi E, Frigerio L, Crea P, Zagari D, Casula M, Sangiorgi G, Persampieri S, Dell'Era G, Patti G, Colombo C, Mugnai G, Notaristefano F, Barengo A, Falcetti R, Perego GB, D'Angelo G, Tanese N, Currao A, Sgromo V, De Ferrari GM; STAR study group. Electrical storm tr PMID 38289867
Identifiers
NCT: NCT07211347 · 7.441.184