An observational study in Arrhythmic Storm, Electrical Storm and Ventricular Fibrillation, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Recruiting at 38 sites in 2 countries. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Observational
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.
This is an international multicenter observational retrospective and prospective short term (24 hours) longitudinal study, promoted and coordinated by the Fondazione IRCCS Policlinico San Matteo of Pavia (Italy).
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:
PSGB technique:
Both the two approaches present in literature and commonly used for this technique are allowed for the study:
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:
The feasibility of the procedure expressed as the number of complications within 12 hours from the procedure. The following complications will be considered:
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.
186 studies on the registry are indexed under Ventricular Fibrillation; 37 are open to participants now.
This study's planned enrollment of 500 is above the median of 450 across 82 observational studies indexed under Ventricular Fibrillation.
Browse Ventricular Fibrillation studies →Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 257 studies on the registry; 114 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Both the two approaches present in literature and commonly used for this technique are allowed for the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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.
Time frame: 12h before and 12h after the procedure
reduction of arrhythmic relapses after PSGB
the effectiveness of the technique will be evaluated by the comparison of the number of shocks before and after the procedure
Time frame: 12h before and 12h after the procedure
complication rate related to PSGB
The feasibility of the procedure will be 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
Time frame: 12 hours after the procedure
relationship between the appearance of anisocoria and the reduction of arrhythmic relapses after PSGB
The comparison of the effectiveness endpoint in patients with and without the appearance of anisocoria
Time frame: 12h before and 12h after the procedure
relationship between the approach used and the reduction of arrhythmic relapses after PSGB
The comparison of effectiveness between patients who will receive "anatomical" PSGB and those who will receive echo-guided PSGB.
Time frame: 12h before and 12h after the procedure
relationship between the administration type and the reduction of the arrhythmic relapses after PSGB.
The comparison of effectiveness between patients who will receive continuous anesthetic infusion and patients who will receive a single bolus in the site of PSGB.
Time frame: 12h before and 12h after the procedure
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Undecided — every study site will be able to have data regarding their patients
Started Nov 2017 (actual). Primary completion is estimated for Dec 2028, 133 months after the start.
Of 28 observational studies under Ventricular Fibrillation, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 39. This study's planned 133 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondazione IRCCS Policlinico San Matteo di Pavia →