Using Stellate Ganglion Block to Treat Arrhythmic Storm
A Multicenter Observational Study on In-hospital Stellate Ganglion Block for Arrhythmic Storm
This study is testing if a special nerve block can help people having a severe heart rhythm problem called arrhythmic storm by reducing the number of shocks they need from a defibrillator.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 38 sites (Alessandria, AL and 37 other locations) |
| Trial ID | NCT05720936 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of Percutaneous Stellate Ganglion Block (PSGB) in patients experiencing an arrhythmic storm, which is characterized by multiple sustained ventricular arrhythmias within a 24-hour period that do not respond to standard antiarrhythmic medications. Patients who meet the inclusion criteria will undergo PSGB and will be monitored for changes in the number of defibrillations required before and after the procedure. The study is multicenter and includes both retrospective and prospective data collection over a short-term period of 24 hours. The aim is to gather evidence on the potential benefits of this neuromodulation technique in emergency situations.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are experiencing an arrhythmic storm that is unresponsive to at least one antiarrhythmic drug.
Not a fit: Patients with a history of cardiac sympathicectomy or those with neck conditions that make the procedure unsuitable will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients suffering from refractory arrhythmic storms.
How similar studies have performed: While neuromodulation techniques like PSGB have shown promise in smaller studies, this is one of the first large multicentric studies aimed at evaluating its safety and effectiveness in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Alessandria, AL and 37 other locations
- 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, 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 — 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)
Study contacts
- Study coordinator: Simone Savastano, MD
- Email: s.savastano@smatteo.pv.it
- Phone: +39 0382501590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.