Nerve block in the neck versus amiodarone for electrical storm of the heart
Compares a stellate ganglion block with amiodarone in adults with electrical storm.
Key facts
- Who runs it
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Where
- Pavia, ItalySee the site
- Trial code
- Registry title
- Percutaneous Stellate Ganglion Block as First Line Treatment in Patients With Electrical Storm: the STAR 2 Study
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 180 people, planned
- Started
- 1 Oct 2026
- Expected to end
- 31 Dec 2029
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- L-PSGB first
- Record updated
- 29 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with electrical storm, meaning repeated fast dangerous heart rhythms (VT/VF) needing defibrillator treatment. It compares a stellate ganglion block (a numbing injection in the neck) with intravenous amiodarone as first treatment.
- Age
- 18 years and older
- Sex
- All sexes can join
- Disease stage
- More than 3 episodes of fast VT/VF treated by an internal or external defibrillator in the 12 hours before randomization, with at least one in the 3 hours before. People may have any structural heart disease, acute or chronic coronary disease, or CPVT.
- Earlier treatment
- People cannot join if they had a heart transplant, surgical sympathetic denervation or ablation of the stellate ganglion before. People currently on intravenous antiarrhythmic drugs usually cannot join.
Main reasons for not taking part
- Brugada syndrome or early repolarization syndrome
- Neck judged not workable for the procedure, or cardiac arrest that does not respond to treatment
- Pregnancy or breastfeeding
- Allergy to amiodarone, lidocaine or bupivacaine, or reasons these drugs cannot be used (such as long QT, heart block without a pacemaker, active hyperthyroidism, severe low blood pressure)
- Investigational drug in another trial within 30 days of screening or within 5 half-lives, whichever is longer
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Age ≥ 18 years
- More than 3 episodes of fast-VT/VF treated by the internal or external defibrillator in the 12 hours before randomization and at least one in the three hours before
- Fast-VT or FV requiring internal or external treatment
- Any structural heart disease
- Acute or choric coronary disease
- CPVT
Who cannot take part
- Previous heart transplantation
- Previous surgical sympathetic denervation
- Previous ablation of the stellate ganglion block
- Ongoing treatment with intravenous AAD drugs. Enrolment may be possible under certain circumstances (see Table 3 page 62-63) in case of recurrences after discontinuation
- Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drugs whichever is longer
- Known allergy or hypersensitivity or previous idiosyncrasy to amiodarone, lidocaine, bupivacaine or to any of the excipients
- Brugada syndrome or early repolarization syndrome
- Refractory cardiac arrest
- Contraindications to amiodarone or other study drugs (e.g. QT interval prolongation or known Long-QT syndrome, sick sinus syndrome, without a pacemaker; second- or third-degree AV block, without a pacemaker, active hyperthyroidism, severe hypotension, porphyria, untreated pheochromocytoma)
- Neck judged unfeasible for the procedure by the clinicians
- Pregnancy or breastfeeding
Where in Italy
- Cardiology Division, Fondazione IRCCS Policlinico San Matteo of PaviaPavia, ItalyContact: Simone Savastano, MD (study PI)No longer taking part
About the trial
What the trial wants to find out
Electrical storm (ES) is a life-threatening condition characterized by recurrent episodes of ventricular tachycardia (VT) or ventricular fibrillation (VF) requiring anti-tachycardia pacing or defibrillator shocks. Despite advances in management, ES remains associated with high morbidity and mortality, and current pharmacological options are often insufficient or slow-acting.
Read full original descriptionShow less
The STAR 2 study is a multicentre, randomized, open-label, adaptive superiority trial designed to evaluate whether percutaneous stellate ganglion block (PSGB) as first-line therapy is superior to intravenous amiodarone in patients with ES. The primary hypothesis is that PSGB administered as initial treatment will result in a higher proportion of patients achieving complete suppression of treated ventricular arrhythmias during the first three hours after treatment compared with intravenous amiodarone.
Adult patients presenting with electrical storm, defined as three or more episodes of fast VT/VF (cycle length <400 ms) treated by internal or external defibrillator within the preceding 12 hours, including at least one episode in the three hours before randomization, will be eligible for participation. Patients will be randomly assigned in a 1:1 ratio to receive either PSGB or intravenous amiodarone as first-line treatment.
In the intervention arm, patients will undergo left PSGB using a combination of 200 mg lidocaine and 50 mg bupivacaine injected percutaneously at the level of the left stellate ganglion. The procedure may be repeated once within the first three hours in case of arrhythmic recurrence, without exceeding maximum recommended doses. In the control arm, patients will receive intravenous amiodarone according to a standardized protocol consisting of a 300-mg loading dose over 30 minutes followed by 900 mg infused over 18-24 hours.
The primary outcome is the proportion of patients with complete suppression of treated ventricular arrhythmias (defined as VT/VF episodes requiring anti-tachycardia pacing, internal cardioverter-defibrillator shock, or external defibrillator shock) during the first three hours after treatment administration. Secondary outcomes include time to first recurrence of ventricular arrhythmia within three hours, per-patient rate of treated ventricular arrhythmias in the first three and twelve hours after treatment, crossover rate between treatment arms, survival to hospital discharge, and survival at one month. Safety outcomes will include procedure- and drug-related complications and adverse events.
The study plans to enroll up to 180 patients across multiple centres. An adaptive design with pre-specified interim analyses for futility and efficacy will be employed, allowing for early termination if predefined statistical boundaries are crossed. Participants will be followed throughout hospitalization and for 30 days after discharge.
This trial aims to provide robust evidence on the comparative effectiveness and safety of PSGB versus standard antiarrhythmic therapy when used as first-line treatment in patients with electrical storm, potentially supporting a shift in current management strategies.
The 2 groups in the trial
- Amiodarone first (SoC)No study treatment, for comparison
Control group receiving intravenous amiodarone infusion as first-line treatment. According to guidelines Amiodarone is the most commonly used intravenous antiarrhythmic drug and represents the current standard of care.
- L-PSGB firstTreatment being tested
Intervention group receiving left percutaneous stellate ganglion block (L-PSGB) as first-line treatment. The procedure consists of a single injection (bolus), at the level of the left-sided Chassaignac's tubercle (C6), of a combination of 200 mg lidocaine and 50 mg bupivacaine. Repetition of PSGB can be considered in case of arrhythmic recurrence within the first three hours.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Multicentre Randomised Study on Percutaneous Stellate Ganglion Block as First Line Treatment in Patients With Electrical Storm: the STAR 2 Study.
- Plain-language title
- Nerve block in the neck versus amiodarone for electrical storm of the heartGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 29 September 2026