In-hospital Stellate Ganglion Block for Arrhythmic Storm

NCT05720936 | Recruiting DMC

• 1 other identifier: STAR Study
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 38

Brief Summary

Arrhythmic storm is a real emergency and its treatment could be challenging. Antiarrhythmic drugs are few and often ineffective. Neuromodulation has been grown in evidences but no large multicentric studies are present in literature about safety and effectiveness of Percutaneous Stellate Ganglion Block (PSGB). Patients with an electrical storm refractory to at least one antiarrhythmic drug will receive PSGB and will be enrolled in the present study. The number of defibrillations before and after the treatment will be compared, complications will be annotated.

Conditions

Arrhythmic Storm; Electrical Storm; Ventricular Fibrillation; Ventricular Tachycardia

Keywords

PSGB; L-PSGB; Percutaneous Stellate Ganglion Block; Percutaneous Stellate Ganglion Blockade; Electrical Storm

Outcome Measures

Primary Outcomes (1)

• reduction of arrhythmic relapses after PSGB

  effectiveness of the PSGB expressed by the reduction of arrhythmic relapses (number of DC shocks or anti-tachycardia pacing ATP) of at least 50% after PSGB.

  12h before and 12h after the procedure

Secondary Outcomes (5)

• reduction of arrhythmic relapses after PSGB

  12h before and 12h after the procedure

• complication rate related to PSGB

  12 hours after the procedure

• relationship between the appearance of anisocoria and the reduction of arrhythmic relapses after PSGB

  12h before and 12h after the procedure

• relationship between the approach used and the reduction of arrhythmic relapses after PSGB

  12h before and 12h after the procedure

• relationship between the administration type and the reduction of the arrhythmic relapses after PSGB.

  12h before and 12h after the procedure

Study Arms (1)

patients with electric storm

patients with electric storm defined as the occurrence of at least three episodes of ventricular fibrillation/tachycardia in 24 hours

Procedure: Percutaneous stellate ganglion block (PSGB)

Interventions

Percutaneous stellate ganglion block (PSGB) PROCEDURE

Both the two approaches present in literature and commonly used for this technique are allowed for the study: * The "anatomical" approach which consist in the identification of the Chassaignac's tubercle that represents the point of needle insertion * The "echo-guided" approach

patients with electric storm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All the patients who will meet the inclusion criteria will be enrolled in the study. Conscious patients with a sufficient free interval between arrhythmic relapses will sign the informed consent for the procedure and for data collection (attached at the study protocol) before the procedure. In case of unconscious patients the medical doctor will perform the procedure being in an emergency situation and the inform consent for data collection will be signed afterward once possible.

You may qualify if:

• age ≥ 18 years,
• presence of arrhythmic storm defined as more than three sustained ventricular arrhythmias in 24 hours refractory to the standard medical treatment.

You may not qualify if:

• A previous history of cardiac sympathicectomy
• Having a neck judged unsuitable for the procedure (previous neck surgery, previous burns, presence of large scars, thyroid goiter)
• Both the two approaches present in literature and commonly used for this technique are allowed for the study:
• The "anatomical" approach which consist in the identification of the Chassaignac's tubercle that represents the point of needle insertion
• The "echo-guided" approach Regardless to the approach (anatomical or echo-guided) the doctor will be able to choose, according to the clinical characteristics of the patients, whether to perform a single shot injection of anesthetic or a continuous infusion of anesthetic. In the second case a catheter will be left in place and connected to an infusion pump.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (38)

A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria.

Alessandria, AL, Italy

RECRUITING

Ospedale di Bentivoglio

Bentivoglio, BO, Italy

RECRUITING

Ospedale Maggiore di Bologna

Bologna, BO, Italy

RECRUITING

Cardiology Department, Fondazione IRCCS Policlinico San Matteo

Pavia, PV, 27100, Italy

RECRUITING

Ospedale Civile

Voghera, PV, Italy

RECRUITING

Ospedale Mater Salutis

Legnago, VR, Italy

RECRUITING

A.O.U. delle Marche, Ospedali Riuniti

Ancona, Italy

RECRUITING

Ospedale Cardinal Massaia

Asti, Italy

RECRUITING

Policlinico S. Orsola-Malpighi, IRCCS A.O.U. Bologna

Bologna, Italy

RECRUITING

P.O. "San Michele" dell'ARNAS "G. Brotzu" di Cagliari

Cagliari, Italy

RECRUITING

Istituto clinico Humanitas Mater Domini di Castellanza

Castellanza, Italy

RECRUITING

Ospedale Maggiore

Crema, Italy

RECRUITING

Ospedale San Biagio di Domodossola

Domodossola, Italy

RECRUITING

Ospedale S. Maria Annunziata

Florence, Italy

RECRUITING

P.O. Santa Maria Nuova e Palagi

Florence, Italy

RECRUITING

Ospedale Misericordia di Grosseto.

Grosseto, Italy

RECRUITING

Ospedale di Gubbio-Gualdo Tadino, USL Umbria 1

Gubbio, Italy

RECRUITING

Ospedale Civile di Ivrea

Ivrea, Italy

RECRUITING

Ospedale Alessandro Manzoni

Lecco, Italy

RECRUITING

Azienda USL Toscana Nord Ovest, Presidio di Livorno

Livorno, Italy

RECRUITING

A.O.U. Policlinico "G. Martino" di Messina.

Messina, Italy

RECRUITING

ASST Santi Paolo e Carlo

Milan, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

Istituto Auxologico Italiano

Milan, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda di Milano

Milan, Italy

RECRUITING

Ospedale V. Monaldi - AOS dei Colli

Napoli, Italy

RECRUITING

A.O.U. Maggiore della Carità di Novara

Novara, Italy

RECRUITING

Azienda Ospedale Università Padova

Padua, Italy

RECRUITING

Ospedale S. Maria della Misericordia - Perugia

Perugia, Italy

RECRUITING

Ospedale "Infermi" AUSL Romagna

Rimini, Italy

RECRUITING

A.O.U. Ospedale Sant'Andrea

Roma, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore

Roma, Italy

RECRUITING

Fondazione PTV Policlinico Tor Vergata di Roma

Roma, Italy

RECRUITING

Ospedale Fatebenefratelli di Roma.

Roma, Italy

ACTIVE NOT RECRUITING

Ospedale San Paolo

Savona, Italy

RECRUITING

Ospedale Molinette di Torino

Torino, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata - Verona

Verona, Italy

RECRUITING

Istituto Cardiocentro Ticino

Lugano, Switzerland

ACTIVE NOT RECRUITING

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

• Savastano S, Dusi V, Baldi E, Rordorf R, Sanzo A, Camporotondo R, Fracchia R, Compagnoni S, Frigerio L, Oltrona Visconti L, De Ferrari GM. Anatomical-based percutaneous left stellate ganglion block in patients with drug-refractory electrical storm and structural heart disease: a single-centre case series. Europace. 2021 Apr 6;23(4):581-586. doi: 10.1093/europace/euaa319.

  PMID: 33190159 BACKGROUND

• Savastano S, Pugliese L, Baldi E, Dusi V, Tavazzi G, De Ferrari GM. Percutaneous continuous left stellate ganglion block as an effective bridge to bilateral cardiac sympathetic denervation. Europace. 2020 Apr 1;22(4):606. doi: 10.1093/europace/euaa007. No abstract available.

  PMID: 32034906 BACKGROUND

• Savastano S, Baldi E, Camporotondo R, Belliato M, Marinoni B, De Ferrari GM. Percutaneous stellate ganglion block and extracorporeal cardiopulmonary resuscitation: an effective and safe combination for refractory ventricular fibrillation. Europace. 2020 Jan 1;22(1):148. doi: 10.1093/europace/euz180. No abstract available.

  PMID: 31257420 BACKGROUND

• Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.

  PMID: 36017572 BACKGROUND

MeSH Terms

Conditions

Ventricular Fibrillation; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Simone Savastano, MD

CONTACT

+39 0382501590; s.savastano@smatteo.pv.it

Alessia Currao, PharmD (CRC)

CONTACT

+39 0382501590; a.currao@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2023
• First Posted: February 9, 2023
• Study Start: November 7, 2017
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

IT (37); CH (1)