Percutaneous Blockade of the Stellate Ganglion in Electrical Storm

NCT07211347 | Recruiting Phase 4

• 1 other identifier: 7.441.184
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Electrical Storm; Stellate Ganglion Block; Ventricular Arrhythmia

Keywords

Ventricular Arrhythmia; Electrical Storm; Stellate ganglion block

Outcome Measures

Primary Outcomes (1)

• Reduction in arrhythmic events

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

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

Secondary Outcomes (2)

• ICD therapies

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

• Urgent ablation and other invasive therapies

  72 hours after the blockade

Study Arms (2)

Stellate Ganglion Block

ACTIVE COMPARATOR

Procedure: Stellate Ganglion Block

Standard Treatment

NO INTERVENTION

Interventions

Stellate Ganglion Block PROCEDURE

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.

Stellate Ganglion Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Clinical Research Center of the Heart Institute - University of São Paulo

São Paulo, São Paulo, 05409011, Brazil

RECRUITING

Related Publications (1)

• 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 treatment by percutaneous stellate ganglion block: the STAR study. Eur Heart J. 2024 Mar 7;45(10):823-833. doi: 10.1093/eurheartj/ehae021.

  PMID: 38289867 BACKGROUND

Study Officials

• Maurício I Scanavacca, MD, PhD

  Instituto do Coração - HC/FMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto P Ferraz, MD

CONTACT

+5511981043839; albertopferraz@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: October 7, 2025
• Study Start: June 6, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)