Percutaneous Blockade of the Stellate Ganglion in Electrical Storm

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Stellate Ganglion Block

    Procedure/Surgery

    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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Stellate Ganglion BlockActive comparator 1 intervention
Group B: Standard TreatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Reduction in arrhythmic events

A ≥50% reduction in arrhythmic events (VT/VF)

Time frame
12 hours immediately after the blockade compared to the 12 hours immediately before

Secondary outcomes

1

ICD therapies

Reduction in the number of ATPs/ICD shocks

Time frame
12 hours immediately after stellate ganglion block (SGB) compared to the 12 hours immediately before
2

Urgent ablation and other invasive therapies

urgent ablation and other invasive therapies (e.g., intra-aortic balloon pump placement or intubation for deep sedation)

Time frame
72 hours after the blockade

Other outcomes

Sponsors and contacts

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