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临床试验/NCT07841080
NCT07841080尚未招募3 期

A Multicentre Randomised Study on Percutaneous Stellate Ganglion Block as First Line Treatment in Patients With Electrical Storm: the STAR 2 Study.

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
180
试验地点
1
主要终点
Complete Suppression of treated VAs (ATP/DC shock) within 3 hours

研究概览

简要总结

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.

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.

详细描述

Electrical storm (ES) is a critical manifestation of electrical instability of the heart, characterized by clustered episodes of ventricular tachycardia (VT) or ventricular fibrillation (VF) that trigger repeated interventions by implantable cardioverter-defibrillators or require external defibrillation. Beyond the immediate risk of hemodynamic collapse and cardiac arrest, ES is associated with repeated myocardial injury from shocks, psychological distress, prolonged intensive care stays, and increased short- and medium-term mortality. Contemporary cohorts indicate that ES occurs in approximately 5% of patients with an ICD implanted for primary prevention and in up to 25% of those implanted for secondary prevention, underscoring its clinical relevance.

The pathophysiology of ES involves a dynamic interaction between an arrhythmogenic substrate, often related to structural heart disease or channelopathies, and transient triggers that promote initiation and maintenance of ventricular arrhythmias. Among these triggers, heightened sympathetic activity plays a central role. Experimental work beginning in the late 1960s demonstrated that acute myocardial ischemia activates sympathetic afferents before electrocardiographic changes become evident, and that direct stimulation of the left stellate ganglion can induce delayed afterdepolarizations and lower the threshold for VF. Conversely, left cardiac sympathetic denervation raises the fibrillation threshold and reduces arrhythmic vulnerability. These observations established the conceptual foundation for targeting the sympathetic nervous system in the management of malignant ventricular arrhythmias.

Despite this well-characterized pathophysiology, current guideline-directed management of ES remains anchored in pharmacological antiarrhythmic therapy, with intravenous amiodarone as the most widely adopted first-line agent. Amiodarone is recommended by European and American guidelines for recurrent VT/VF and advanced life support scenarios. However, its onset of action is not immediate, efficacy in refractory ES is variable, and its administration is not devoid of acute adverse effects, including hypotension, bradycardia, and potential proarrhythmia. In patients with recurrent shocks despite pharmacological therapy, additional options such as deep sedation, general anaesthesia, catheter ablation, or surgical sympathetic denervation may be considered, but these approaches are not universally available, may require significant resources, and are not always feasible in unstable patients.

In this context, percutaneous stellate ganglion block (PSGB) has emerged as a rapid, minimally invasive neuromodulatory intervention that can be performed at the bedside with equipment commonly available in cardiology and critical care settings. PSGB involves percutaneous injection of local anaesthetics near the left stellate ganglion, resulting in temporary blockade of sympathetic efferent fibres innervating the heart. Two main techniques have been described: an anterior anatomical approach based on palpation of the Chassaignac tubercle at the C6 level, and a lateral ultrasound-guided approach targeting the prevertebral space over the longus colli muscle. Both techniques have been employed in observational studies with comparable efficacy and safety profiles.

Clinical evidence supporting PSGB in ES has accumulated over the past two decades. Early case reports described successful termination of drug-resistant VT and VF following left PSGB in patients with prolonged QT interval and structural heart disease. Subsequent monocentric retrospective series consistently reported marked reductions in arrhythmic burden and ICD shocks after PSGB, often with complete suppression of treated arrhythmias in a substantial proportion of patients. More recently, two multicentre observational studies have provided more robust evidence. The STAR study, promoted by our group and involving 19 Italian centres, enrolled 131 patients who underwent 184 PSGB procedures. In that study, 92% of patients achieved a reduction of at least 50% in treated ventricular arrhythmias in the 12 hours following the last procedure, with a median reduction of 100%. A significant decrease in arrhythmic episodes was observed both in per-procedure analysis comparing the hour before and after each block, and in per-patient analysis comparing the 12 hours before and after the intervention. Importantly, only one major complication occurred, supporting an excellent safety profile even in a population frequently receiving antiplatelet and anticoagulant therapy. A second multicentre study from the United States and Czech Republic confirmed these findings, demonstrating significant reductions in VT/VF episodes and defibrillation events in the 24 hours following PSGB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

The event adjudication committee will blindly adjudicate the arrhythmics events

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Brugada syndrome or early repolarization syndrome
  • •Neck judged unfeasible for the procedure by the clinicians
  • •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
  • •Refractory cardiac arrest
  • •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
  • •Pregnancy or breastfeeding
  • •Known allergy or hypersensitivity or previous idiosyncrasy to amiodarone, lidocaine, bupivacaine or to any of the excipients
  • •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)

研究组 & 干预措施

Amiodarone first (SoC)

No Intervention

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 first

Experimental

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.

干预措施: L-PSGB first (Drug)

结局指标

主要结局

Complete Suppression of treated VAs (ATP/DC shock) within 3 hours

时间窗: within 3 hours from treatment

Proportion of patients with complete suppression of treated VA (with ATP, internal DC shock or external DC shock) during the first three hours after treatment.

次要结局

  • Secondary Outcome 1(within 3 hours from treatment)
  • Secondary Outcome 2(within 3 hours from treatment)
  • Secondary Outcome 3(±3 hours from treatment administration)
  • Secondary Outcome 4(In the first 12 hours after treatment administration)
  • Secondary Outcome 5(at 12 hours post-treatment)
  • Secondary Outcome 6(from index treatment to hospital discharge (maximum 30 days))
  • Secondary Outcome 7(from index treatment to 1 month follow-up)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Savastano

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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