Blocking nerves and saving lives: Left stellate ganglion block for electrical storms.
Simone Savastano, Peter J Schwartz
https://pubmed.ncbi.nlm.nih.gov/36509320Actively Recruiting
All Genders
ID05720936
A Multicenter Observational Study on In-hospital Stellate Ganglion Block for Arrhythmic Storm
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-06-08
500
Participants Needed
38
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients experiencing arrhythmic storm, a serious heart condition characterized by frequent and sustained ventricular arrhythmias that do not respond to standard antiarrhythmic drugs. This international multicenter observational study aims to evaluate the safety and effectiveness of Percutaneous Stellate Ganglion Block (PSGB) in reducing arrhythmic relapses in such emergency cases. The study is coordinated by Fondazione IRCCS Policlinico San Matteo of Pavia, Italy, and addresses a gap in large-scale data on this procedure. Participants who meet the criteria will receive PSGB using either the anatomical or echo-guided approach. Depending on patient needs, the procedure may involve a single anesthetic injection or continuous anesthetic infusion via a catheter connected to a pump. The study compares the number of arrhythmic events and defibrillations before and after PSGB treatment and notes any complications occurring within 12 hours post-procedure. During participation, patients will be monitored closely for arrhythmic relapses using defibrillation counts and anti-tachycardia pacing data. Complications such as hematomas, vascular injuries, and nerve damage will be recorded. Data are collected using a secure electronic system, with effectiveness measured by arrhythmic event reduction in the 12 hours following PSGB compared to the 12 hours prior. The study plans to enroll patients over several years with ongoing safety and outcome evaluations.
CONDITIONS
Brief Title
In-hospital Stellate Ganglion Block for Arrhythmic Storm
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Presence of arrhythmic storm defined as more than three sustained ventricular arrhythmias in 24 hours refractory to standard medical treatment
You will not qualify if you...
- Previous history of cardiac sympathicectomy
- Neck unsuitable for the procedure due to previous neck surgery, burns, large scars, or thyroid goiter
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Procedure and up to 12 hours post-procedure
Participants undergo the percutaneous stellate ganglion block (PSGB) procedure using either the anatomical or echo-guided approach. The procedure involves either a single injection or continuous infusion of anesthetic.
1 procedure visit and monitoring for 12 hours afterward
Monitoring
Duration - 12 hours post-implementation
Participants are observed for effectiveness and complications related to the PSGB procedure, including arrhythmic relapse reduction and any procedure-related adverse events within 12 hours after the procedure.
Continuous monitoring during the 12 hours after the procedure
Trial Site Locations
Total: 38 locations
1
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria.
Alessandria, AL, Italy
Actively Recruiting
2
Ospedale di Bentivoglio
Bentivoglio, BO, Italy
Actively Recruiting
3
Ospedale Maggiore di Bologna
Bologna, BO, Italy
Actively Recruiting
4
Cardiology Department, Fondazione IRCCS Policlinico San Matteo
Pavia, PV, Italy, 27100
Actively Recruiting
5
Ospedale Civile
Voghera, PV, Italy
Actively Recruiting
6
Ospedale Mater Salutis
Legnago, VR, Italy
Actively Recruiting
7
A.O.U. delle Marche, Ospedali Riuniti
Ancona, Italy
Actively Recruiting
8
Ospedale Cardinal Massaia
Asti, Italy
Actively Recruiting
9
Policlinico S. Orsola-Malpighi, IRCCS A.O.U. Bologna
Bologna, Italy
Actively Recruiting
10
P.O. "San Michele" dell'ARNAS "G. Brotzu" di Cagliari
Cagliari, Italy
Actively Recruiting
11
Istituto clinico Humanitas Mater Domini di Castellanza
Castellanza, Italy
Actively Recruiting
12
Ospedale Maggiore
Crema, Italy
Actively Recruiting
13
Ospedale San Biagio di Domodossola
Domodossola, Italy
Actively Recruiting
14
Ospedale S. Maria Annunziata
Florence, Italy
Actively Recruiting
15
P.O. Santa Maria Nuova e Palagi
Florence, Italy
Actively Recruiting
16
Ospedale Misericordia di Grosseto.
Grosseto, Italy
Actively Recruiting
17
Ospedale di Gubbio-Gualdo Tadino, USL Umbria 1
Gubbio, Italy
Actively Recruiting
18
Ospedale Civile di Ivrea
Ivrea, Italy
Actively Recruiting
19
Ospedale Alessandro Manzoni
Lecco, Italy
Actively Recruiting
20
Azienda USL Toscana Nord Ovest, Presidio di Livorno
Livorno, Italy
Actively Recruiting
21
A.O.U. Policlinico "G. Martino" di Messina.
Messina, Italy
Actively Recruiting
22
ASST Santi Paolo e Carlo
Milan, Italy
Actively Recruiting
23
IRCCS Ospedale San Raffaele
Milan, Italy
Actively Recruiting
24
Istituto Auxologico Italiano
Milan, Italy
Actively Recruiting
25
ASST Grande Ospedale Metropolitano Niguarda di Milano
Milan, Italy
Actively Recruiting
26
Ospedale V. Monaldi - AOS dei Colli
Naples, Italy
Actively Recruiting
27
A.O.U. Maggiore della Carità di Novara
Novara, Italy
Actively Recruiting
28
Azienda Ospedale Università Padova
Padova, Italy
Actively Recruiting
29
Ospedale S. Maria della Misericordia - Perugia
Perugia, Italy
Actively Recruiting
30
Ospedale "Infermi" AUSL Romagna
Rimini, Italy
Actively Recruiting
31
A.O.U. Ospedale Sant'Andrea
Roma, Italy
Actively Recruiting
32
Fondazione Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore
Roma, Italy
Actively Recruiting
33
Fondazione PTV Policlinico Tor Vergata di Roma
Roma, Italy
Actively Recruiting
34
Ospedale Fatebenefratelli di Roma.
Roma, Italy
Active, Not Recruiting
35
Ospedale San Paolo
Savona, Italy
Actively Recruiting
36
Ospedale Molinette di Torino
Torino, Italy
Actively Recruiting
37
Azienda Ospedaliera Universitaria Integrata - Verona
Verona, Italy
Actively Recruiting
38
Istituto Cardiocentro Ticino
Lugano, Switzerland
Active, Not Recruiting
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Research Team
S
Simone Savastano, MD
A
Alessia Currao, PharmD (CRC)
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Anatomical-based percutaneous left stellate ganglion block in patients with drug-refractory electrical storm and structural heart disease: a single-centre case series.
Simone Savastano, Veronica Dusi, Enrico Baldi...
https://pubmed.ncbi.nlm.nih.gov/33190159Percutaneous continuous left stellate ganglion block as an effective bridge to bilateral cardiac sympathetic denervation.
Simone Savastano, Luigi Pugliese, Enrico Baldi...
https://pubmed.ncbi.nlm.nih.gov/32034906Percutaneous stellate ganglion block and extracorporeal cardiopulmonary resuscitation: an effective and safe combination for refractory ventricular fibrillation.
Simone Savastano, Enrico Baldi, Rita Camporotondo...
https://pubmed.ncbi.nlm.nih.gov/312574202022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death.
Katja Zeppenfeld, Jacob Tfelt-Hansen, Marta de Riva...
https://pubmed.ncbi.nlm.nih.gov/36017572