Ireland
--:--IST
Recruiting Observational

In-hospital Stellate Ganglion Block for Arrhythmic Storm

NCT05720936 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2017-11-07
Last updated
2025-06-08

Condition(s) studied

Arrhythmic StormElectrical StormVentricular FibrillationVentricular Tachycardia

Investigational drug(s) / intervention(s)

Percutaneous stellate ganglion block (PSGB)

Percutaneous stellate ganglion block (PSGB): 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

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * age ≥ 18 years, * presence of arrhythmic storm defined as more than three sustained ventricular arrhythmias in 24 hours refractory to the standard medical treatment. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • reduction of arrhythmic relapses after PSGB — 12h before and 12h after the procedure
    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.

Trial sites (38)

FacilityCityRegionStatus
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria. Alessandria AL Recruiting
Ospedale di Bentivoglio Bentivoglio BO Recruiting
Ospedale Maggiore di Bologna Bologna BO Recruiting
Cardiology Department, Fondazione IRCCS Policlinico San Matteo Pavia PV Recruiting
Ospedale Civile Voghera PV Recruiting
Ospedale Mater Salutis Legnago VR 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 Naples Italy Recruiting
A.O.U. Maggiore della Carità di Novara Novara Italy Recruiting
Azienda Ospedale Università Padova Padova 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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05720936 on ClinicalTrials.gov ↗ ← All trials in Italy