In-hospital Stellate Ganglion Block for Arrhythmic Storm
NCT ID: NCT05720936
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
500 participants
OBSERVATIONAL
2017-11-07
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The number of defibrillations before and after the treatment will be compared, complications will be annotated.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Percutaneous Blockade of the Stellate Ganglion in Electrical Storm
NCT07211347
Percutaneous Left Stellate Ganglion Block In Out-of-hospital Cardiac Arrest Due to Refractory VEntricular Arrhythmias (LIVE Study)
NCT04168970
GANGlion Stellate Block for Treatment of Electric storRm (GANGSTER Trial)
NCT05078684
Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）
NCT05770921
Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome
NCT04149886
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Materials and methods:
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.
Inclusion criteria:
All the patients presenting with an 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 by the doctor as non-suitable for the procedure (previous neck surgery, previous burns, presence of large scars, thyroid goiter)
PSGB technique:
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.
Study Objectives:
The primary objective is the effectiveness of the PSGB expressed by the reduction of arrhythmic relapses \[number of Direct Current (DC) shocks or Anti-Tachycardia Pacing ATP\] in the 12 hours immediately after the PSGB as compared to the 6 hours immediately preceding the PSGB of at least 50%.
The secondary objectives are:
1. The comparison of the number of shocks 12h before and 12h after the procedure
2. The feasibility of the procedure expressed as the number of complications within 12 hours from the procedure. The following complications will be considered:
* Simple hematoma
* Symptoms due to anesthetic absorbance
* Hematoma requiring intervention
* Intravascular injection without complication
* Intravascular injection with complication
* Brachial plexus damage
* Simple vascular damage
* Vascular damage requiring intervention
3. The comparison of the effectiveness endpoint in patients with and without the appearance of anisocoria
4. The comparison of effectiveness between patients who will receive "anatomical" PSGB and those who will receive echo-guided PSGB
5. The comparison of effectiveness between patients who will receive anaesthetic infusion in the site of PSGB as compared to those who will not.
Statistics:
Sample size: The investigators plan to enroll patients satisfying the inclusion/exclusion criteria over a time horizon of 5 years. Based on our previous experience over the previous 18 months (enrollment of 8 patients) about 5 patients per year are though to be enrolled, thus reaching a sample size 33 patients in the Pavia Center. The success is effectiveness to be not less then 90%, based on our historical cohort. This will yield a confidence interval of 76% to 98%, corresponding to a precision of 11%. Also, with this sample size it will be able to exclude an effectiveness of 70% (considered as the lower bound of acceptability) with a power of 94% (alpha 2-sided 5%).
With the inclusion of further centers, the increased sample size will allow an increased precision of the estimates; for instance for 100 patients precision would be 6.5% (first step already achieved) and for 500 patients would be 2.6%.
Statistical analysis: Data will be described with the mean and standard deviation or the median and 25th-75th percentile if continuous and counts and percent if categorical.
For the analysis of the primary endpoint the rate of effectiveness together with its 95% exact binomial confidence interval will be computed.
Data management:
Data will be collected using the REDCap platform (e-CRF). A personal and password protected account will be created for each investigator who will be able to access only to the data from his/her Center.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
patients with electric storm
patients with electric storm defined as the occurrence of at least three episodes of ventricular fibrillation/tachycardia in 24 hours
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* presence of arrhythmic storm defined as more than three sustained ventricular arrhythmias in 24 hours refractory to the standard medical treatment.
Exclusion Criteria
* 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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Simone Savastano
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria.
Alessandria, AL, Italy
Ospedale di Bentivoglio
Bentivoglio, BO, Italy
Ospedale Maggiore di Bologna
Bologna, BO, Italy
Cardiology Department, Fondazione IRCCS Policlinico San Matteo
Pavia, PV, Italy
Ospedale Civile
Voghera, PV, Italy
Ospedale Mater Salutis
Legnago, VR, Italy
A.O.U. delle Marche, Ospedali Riuniti
Ancona, , Italy
Ospedale Cardinal Massaia
Asti, , Italy
Policlinico S. Orsola-Malpighi, IRCCS A.O.U. Bologna
Bologna, , Italy
P.O. "San Michele" dell'ARNAS "G. Brotzu" di Cagliari
Cagliari, , Italy
Istituto clinico Humanitas Mater Domini di Castellanza
Castellanza, , Italy
Ospedale Maggiore
Crema, , Italy
Ospedale San Biagio di Domodossola
Domodossola, , Italy
Ospedale S. Maria Annunziata
Florence, , Italy
P.O. Santa Maria Nuova e Palagi
Florence, , Italy
Ospedale Misericordia di Grosseto.
Grosseto, , Italy
Ospedale di Gubbio-Gualdo Tadino, USL Umbria 1
Gubbio, , Italy
Ospedale Civile di Ivrea
Ivrea, , Italy
Ospedale Alessandro Manzoni
Lecco, , Italy
Azienda USL Toscana Nord Ovest, Presidio di Livorno
Livorno, , Italy
A.O.U. Policlinico "G. Martino" di Messina.
Messina, , Italy
ASST Santi Paolo e Carlo
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Istituto Auxologico Italiano
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda di Milano
Milan, , Italy
Ospedale V. Monaldi - AOS dei Colli
Napoli, , Italy
A.O.U. Maggiore della Carità di Novara
Novara, , Italy
Azienda Ospedale Università Padova
Padua, , Italy
Ospedale S. Maria della Misericordia - Perugia
Perugia, , Italy
Ospedale "Infermi" AUSL Romagna
Rimini, , Italy
A.O.U. Ospedale Sant'Andrea
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore
Roma, , Italy
Fondazione PTV Policlinico Tor Vergata di Roma
Roma, , Italy
Ospedale Fatebenefratelli di Roma.
Roma, , Italy
Ospedale San Paolo
Savona, , Italy
Ospedale Molinette di Torino
Torino, , Italy
Azienda Ospedaliera Universitaria Integrata - Verona
Verona, , Italy
Istituto Cardiocentro Ticino
Lugano, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STAR Study
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.