In-hospital Stellate Ganglion Block for Arrhythmic Storm (STAR)

June 4, 2025 updated by: Simone Savastano, Fondazione IRCCS Policlinico San Matteo di Pavia

A Multicenter Observational Study on In-hospital Stellate Ganglion Block for Arrhythmic Storm

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  • 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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Ancona, Italy
      • Asti, Italy
      • Bologna, Italy
        • Recruiting
        • Policlinico S. Orsola-Malpighi, IRCCS A.O.U. Bologna
        • Contact:
      • Cagliari, Italy
        • Recruiting
        • P.O. "San Michele" dell'ARNAS "G. Brotzu" di Cagliari
        • Principal Investigator:
          • Marco Corda, MD
        • Contact:
        • Sub-Investigator:
          • Matteo Casula, MD
      • Castellanza, Italy
        • Recruiting
        • Istituto clinico Humanitas Mater Domini di Castellanza
        • Contact:
        • Principal Investigator:
          • Domenico Zagari, MD
      • Crema, Italy
      • Domodossola, Italy
        • Recruiting
        • Ospedale San Biagio di Domodossola
        • Contact:
        • Principal Investigator:
          • Simone Persamperi, MD
      • Firenze, Italy
      • Firenze, Italy
        • Recruiting
        • P.O. Santa Maria Nuova e Palagi
        • Contact:
      • Grosseto, Italy
        • Recruiting
        • Ospedale Misericordia di Grosseto.
        • Contact:
        • Principal Investigator:
          • Francesco De Sensi
      • Gubbio, Italy
        • Recruiting
        • Ospedale di Gubbio-Gualdo Tadino, USL Umbria 1
        • Contact:
      • Ivrea, Italy
      • Lecco, Italy
      • Livorno, Italy
      • Messina, Italy
        • Recruiting
        • A.O.U. Policlinico "G. Martino" di Messina.
        • Contact:
        • Principal Investigator:
          • Pasquale Crea, MD
      • Milan, Italy
      • Milan, Italy
        • Recruiting
        • Istituto Auxologico Italiano
        • Contact:
      • Milan, Italy
      • Milano, Italy
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda di Milano
        • Contact:
        • Principal Investigator:
          • Claudia Colombo, MD
      • Napoli, Italy
      • Novara, Italy
        • Recruiting
        • A.O.U. Maggiore della Carita di Novara
        • Contact:
        • Principal Investigator:
          • Gabriele Dell'Era, MD
      • Padova, Italy
      • Perugia, Italy
        • Recruiting
        • Ospedale S. Maria della Misericordia - Perugia
        • Contact:
        • Principal Investigator:
          • Francesco Notaristefano, MD
      • Rimini, Italy
      • Roma, Italy
        • Recruiting
        • Fondazione Ptv Policlinico Tor Vergata Di Roma
        • Contact:
        • Principal Investigator:
          • Giuseppe Sangiorgi, MD
      • Roma, Italy
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore
        • Contact:
      • Roma, Italy
        • Active, not recruiting
        • Ospedale Fatebenefratelli di Roma.
      • Savona, Italy
      • Torino, Italy
      • Verona, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata - Verona
        • Contact:
        • Principal Investigator:
          • Giacomo Mugnai, MD
    • AL
      • Alessandria, AL, Italy
        • Recruiting
        • A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria.
        • Contact:
        • Principal Investigator:
          • Edoardo Gandolfi, MD
    • BO
      • Bentivoglio, BO, Italy
      • Bologna, BO, Italy
        • Recruiting
        • Ospedale Maggiore di Bologna
        • Principal Investigator:
          • Gianmarco Iannopollo, MD
        • Contact:
    • PV
      • Pavia, PV, Italy, 27100
        • Recruiting
        • Cardiology Department, Fondazione IRCCS Policlinico San Matteo
        • Sub-Investigator:
          • Enrico Baldi, MD
        • Principal Investigator:
          • Simone Savastano, MD
        • Sub-Investigator:
          • Roberto Rordorf, MD
        • Contact:
        • Contact:
      • Voghera, PV, Italy
    • VR
  • Switzerland
      • Lugano, Switzerland
        • Active, not recruiting
        • Istituto Cardiocentro Ticino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with electric storm
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of arrhythmic relapses after PSGB
Time Frame: 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.
12h before and 12h after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of arrhythmic relapses after PSGB
Time Frame: 12h before and 12h after the procedure
the effectiveness of the technique will be evaluated by the comparison of the number of shocks before and after the procedure
12h before and 12h after the procedure
complication rate related to PSGB
Time Frame: 12 hours after the procedure

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
12 hours after the procedure
relationship between the appearance of anisocoria and the reduction of arrhythmic relapses after PSGB
Time Frame: 12h before and 12h after the procedure
The comparison of the effectiveness endpoint in patients with and without the appearance of anisocoria
12h before and 12h after the procedure
relationship between the approach used and the reduction of arrhythmic relapses after PSGB
Time Frame: 12h before and 12h after the procedure
The comparison of effectiveness between patients who will receive "anatomical" PSGB and those who will receive echo-guided PSGB.
12h before and 12h after the procedure
relationship between the administration type and the reduction of the arrhythmic relapses after PSGB.
Time Frame: 12h before and 12h after the procedure
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.
12h before and 12h after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2017

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 7, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 9, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAR Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

every study site will be able to have data regarding their patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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