[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vf\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vf":52},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100657641","phase-3-percutaneous-stellate-ganglion-block-as-first-line-treatment-in-patients-with-electrical-storm-the-star-2-study-100657641",false,"NCT07841080","Percutaneous Stellate Ganglion Block as First Line Treatment in Patients With Electrical Storm: the STAR 2 Study","A Multicentre Randomised Study on Percutaneous Stellate Ganglion Block as First Line Treatment in Patients With Electrical Storm: the STAR 2 Study.","STAR 2","Inclusion Criteria:\n\n* Age ≥ 18 years\n* More than 3 episodes of fast-VT\u002FVF treated by the internal or external defibrillator in the 12 hours before randomization and at least one in the three hours before.\n* Fast-VT or FV requiring internal or external treatment\n* Any structural heart disease\n* Acute or choric coronary disease\n* CPVT\n\nExclusion Criteria:\n\n* Brugada syndrome or early repolarization syndrome\n* Neck judged unfeasible for the procedure by the clinicians\n* Previous heart transplantation\n* Previous surgical sympathetic denervation\n* Previous ablation of the stellate ganglion block\n* 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\n* Refractory cardiac arrest\n* 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\n* Pregnancy or breastfeeding\n* Known allergy or hypersensitivity or previous idiosyncrasy to amiodarone, lidocaine, bupivacaine or to any of the excipients\n* 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)","ALL","18 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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.\n\nThe 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.\n\nAdult patients presenting with electrical storm, defined as three or more episodes of fast VT\u002FVF (cycle length \\\u003C400 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.\n\nIn 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.\n\nThe primary outcome is the proportion of patients with complete suppression of treated ventricular arrhythmias (defined as VT\u002FVF 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.\n\nThe 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.\n\nThis 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.",[27,28,29,30,31,32],"Electrical Storm","VT","VF","Ventricular Arrhythmia","Ventricular Tachycardia (VT)","Ventricular Fibrillation",[34,35,36,37,38,39],"PSGB","stellate ganglion","percutaneous stellate ganglion block","electrical storm","ventricular arrhythmias","VA","NOT_YET_RECRUITING","2026-09-24",{"date":43,"type":44},"2026-09-29","ACTUAL",{"date":46,"type":21},"2026-10-01",{"date":48,"type":21},"2029-12-31",{"name":50,"class":51},"Fondazione IRCCS Policlinico San Matteo di Pavia","OTHER",""]