Percutaneous Stellate Ganglion Block as First Line Treatment in Patients With Electrical Storm: the STAR 2 Study

NCT07841080 | Not Yet Recruiting Phase 3 DMC

• 3 other identifiers: STAR 2RC 080508242024-520387-34-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Electrical storm (ES) is a life-threatening condition characterized by recurrent episodes of ventricular tachycardia (VT) or ventricular fibrillation (VF) requiring anti-tachycardia pacing or defibrillator shocks. Despite advances in management, ES remains associated with high morbidity and mortality, and current pharmacological options are often insufficient or slow-acting. The STAR 2 study is a multicentre, randomized, open-label, adaptive superiority trial designed to evaluate whether percutaneous stellate ganglion block (PSGB) as first-line therapy is superior to intravenous amiodarone in patients with ES. The primary hypothesis is that PSGB administered as initial treatment will result in a higher proportion of patients achieving complete suppression of treated ventricular arrhythmias during the first three hours after treatment compared with intravenous amiodarone. Adult patients presenting with electrical storm, defined as three or more episodes of fast VT/VF (cycle length \<400 ms) treated by internal or external defibrillator within the preceding 12 hours, including at least one episode in the three hours before randomization, will be eligible for participation. Patients will be randomly assigned in a 1:1 ratio to receive either PSGB or intravenous amiodarone as first-line treatment. In the intervention arm, patients will undergo left PSGB using a combination of 200 mg lidocaine and 50 mg bupivacaine injected percutaneously at the level of the left stellate ganglion. The procedure may be repeated once within the first three hours in case of arrhythmic recurrence, without exceeding maximum recommended doses. In the control arm, patients will receive intravenous amiodarone according to a standardized protocol consisting of a 300-mg loading dose over 30 minutes followed by 900 mg infused over 18-24 hours. The primary outcome is the proportion of patients with complete suppression of treated ventricular arrhythmias (defined as VT/VF episodes requiring anti-tachycardia pacing, internal cardioverter-defibrillator shock, or external defibrillator shock) during the first three hours after treatment administration. Secondary outcomes include time to first recurrence of ventricular arrhythmia within three hours, per-patient rate of treated ventricular arrhythmias in the first three and twelve hours after treatment, crossover rate between treatment arms, survival to hospital discharge, and survival at one month. Safety outcomes will include procedure- and drug-related complications and adverse events. The study plans to enroll up to 180 patients across multiple centres. An adaptive design with pre-specified interim analyses for futility and efficacy will be employed, allowing for early termination if predefined statistical boundaries are crossed. Participants will be followed throughout hospitalization and for 30 days after discharge. This trial aims to provide robust evidence on the comparative effectiveness and safety of PSGB versus standard antiarrhythmic therapy when used as first-line treatment in patients with electrical storm, potentially supporting a shift in current management strategies.

Conditions

Electrical Storm; VT; VF; Ventricular Arrhythmia; Ventricular Tachycardia (VT); Ventricular Fibrillation

Keywords

PSGB; stellate ganglion; percutaneous stellate ganglion block; electrical storm; ventricular arrhythmias; VA

Outcome Measures

Primary Outcomes (1)

• Complete Suppression of treated VAs (ATP/DC shock) within 3 hours

  Proportion of patients with complete suppression of treated VA (with ATP, internal DC shock or external DC shock) during the first three hours after treatment.

  within 3 hours from treatment

Secondary Outcomes (7)

• Time to first recurrence

  within 3 hours from treatment

• Treated ventricular arrhythmias in the first 3 hours

  within 3 hours from treatment

• Number of ventricular arrhythmias 3 hours before and after treatment

  ±3 hours from treatment administration

• Number of crossover

  In the first 12 hours after treatment administration

• Number of treated ventricular arrthythmias in the first 12 hours after treatment

  at 12 hours post-treatment

Study Arms (2)

Amiodarone first (SoC)

NO INTERVENTION

Control group receiving intravenous amiodarone infusion as first-line treatment. According to guidelines Amiodarone is the most commonly used intravenous antiarrhythmic drug and represents the current standard of care.

L-PSGB first

EXPERIMENTAL

Intervention group receiving left percutaneous stellate ganglion block (L-PSGB) as first-line treatment. The procedure consists of a single injection (bolus), at the level of the left-sided Chassaignac's tubercle (C6), of a combination of 200 mg lidocaine and 50 mg bupivacaine. Repetition of PSGB can be considered in case of arrhythmic recurrence within the first three hours.

Drug: L-PSGB first

Interventions

L-PSGB first DRUG

Intervention group receiving left percutaneous stellate ganglion block (L-PSGB) as first-line treatment. The procedure consists of a single injection (bolus), at the level of the left-sided Chassaignac's tubercle (C6), of a combination of 200 mg lidocaine and 50 mg bupivacaine. Repetition of PSGB can be considered in case of arrhythmic recurrence within the first three hours.

L-PSGB first

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• More than 3 episodes of fast-VT/VF treated by the internal or external defibrillator in the 12 hours before randomization and at least one in the three hours before.
• Fast-VT or FV requiring internal or external treatment
• Any structural heart disease
• Acute or choric coronary disease
• CPVT

You may not qualify if:

• Brugada syndrome or early repolarization syndrome
• Neck judged unfeasible for the procedure by the clinicians
• Previous heart transplantation
• Previous surgical sympathetic denervation
• Previous ablation of the stellate ganglion block
• Ongoing treatment with intravenous AAD drugs. Enrolment may be possible under certain circumstances (see Table 3 page 62-63) in case of recurrences after discontinuation
• Refractory cardiac arrest
• Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drugs whichever is longer
• Pregnancy or breastfeeding
• Known allergy or hypersensitivity or previous idiosyncrasy to amiodarone, lidocaine, bupivacaine or to any of the excipients
• Contraindications to amiodarone or other study drugs (e.g. QT interval prolongation or known Long-QT syndrome, sick sinus syndrome, without a pacemaker; second- or third-degree AV block, without a pacemaker, active hyperthyroidism, severe hypotension, porphyria, untreated pheochromocytoma)

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• Azienda Usl di Bologna: collaborator
• Azienda USL Toscana Centro: collaborator
• Azienda Sanitaria Locale N.1 dell'Umbria: collaborator
• Azienda Ospedaliera Brotzu: collaborator
• San Raffaele University Hospital, Italy: collaborator
• Ospedale San Donato: collaborator
• A.O.U. Città della Salute e della Scienza - Molinette Hospital: collaborator
• University Hospital Padova: collaborator
• Azienda Ospedaliera di Perugia: collaborator
• Azienda Ospedaliera Niguarda Cà Granda: collaborator
• Centro Cardiologico Monzino: collaborator
• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: collaborator

Study Sites (1)

Cardiology Division, Fondazione IRCCS Policlinico San Matteo of Pavia

Pavia, PV, 27100, Italy

Location

Related Publications (5)

• Savastano S, Schwartz PJ. Blocking nerves and saving lives: Left stellate ganglion block for electrical storms. Heart Rhythm. 2023 Jul;20(7):1039-1047. doi: 10.1016/j.hrthm.2022.11.025. Epub 2022 Dec 9.

  PMID: 36509320 BACKGROUND

• Baldi E, Rordorf R, Compagnoni S, Dusi V, Sanzo A, Gentile FR, 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, Girardengo G, D'Angelo G, Tanese N, Currao A, Sgromo V, De Ferrari GM, Savastano S; STAR study group. Efficacy of percutaneous stellate ganglion block according to ventricular arrhythmia cycle length: A post hoc subanalysis of the STAR study. Heart Rhythm. 2025 Oct;22(10):2477-2485. doi: 10.1016/j.hrthm.2024.11.015. Epub 2024 Nov 15.

  PMID: 39551122 BACKGROUND

• Currao A, Dusi V, Casula M, Pittorru R, Baldi E, Angelini F, Binaghi G, Migliore F, Gandolfi E, Mugnai G, Tavella D, Notaristefano F, D'Ammando M, Dell'Era G, Falcetti R, Sangiorgi G, D'Angelo G, Scaglione M, Colombo C, Talini E, De Sensi F, Perini AP, Chieffo E, Carinci V, Persampieri S, De Ferrari GM, Savastano S; all the STAR study group. Impact of single vs. dual local anaesthetic regimen on the efficacy and safety of percutaneous stellate ganglion block for electrical storm: new insights from the STAR study. Eur Heart J Cardiovasc Pharmacother. 2026 May 19;12(3):198-208. doi: 10.1093/ehjcvp/pvag011.

  PMID: 41698390 BACKGROUND

• Baldi E, Dusi V, Rordorf R, Currao A, Compagnoni S, Sanzo A, Gentile FR, Frea S, Gravinese C, Angelini F, Cauti FM, Iannopollo G, De Sensi F, Gandolfi E, Frigerio L, Crea P, Zagari D, Casula M, Binaghi G, Sangiorgi G, Barone L, Persampieri S, Dell'Era G, Patti G, Colombo C, Mugnai G, Tavella D, Notaristefano F, Barengo A, Falcetti R, Girardengo G, D'Angelo G, Tanese N, Sgromo V, De Ferrari GM, Savastano S; all the STAR study group. Efficacy of early use of percutaneous stellate ganglion block for electrical storms. Eur Heart J Acute Cardiovasc Care. 2024 Dec 3;13(11):757-765. doi: 10.1093/ehjacc/zuae109.

  PMID: 39317656 BACKGROUND

• 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

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The event adjudication committee will blindly adjudicate the arrhythmics events
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised, double-arm (parallel groups), open label, multicentre, adaptive superiority, controlled Clinical Trial.

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 25, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

IT (1)