Ganglion Stellate Block for Treatment of Electric Storm - a Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in the number of episodes of sustained VT/VF
研究概览
简要总结
This study will evaluate the acute effect of ultrasound-navigated left ganglion stellate block to suppress ventricular arrhythmia in patients with arrhythmic storm.
详细描述
- The study will include patients with drug-refractory arrhythmic storm indicated for left ganglion stellate block (LGSB) before or after catheter ablation.
- Included participants will be dived based on the need for mechanical ventilation and catheter ablation performed <5 days before the study
- Subsequently, the participants will be randomized to LGSB or to a sham (placebo) procedure.
- The primary endpoint will be a reduction of the burden of clinical arrhythmia >50% 24 hours after LGSB without escalation of antiarrhythmic therapy.
- The study will include 80 patients over 4 years.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients, attending staff, and outcome assessors will not know whether the patient received the actual LGSB or a sham (placebo) procedure. The sham procedure will consist of subcutaneous application of a small amount (1ml) of the local anesthetic drug to the region of expected LGSB procedure.
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
- •arrhythmic storm <24 hours before inclusion:
- •3 or more episodes of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) terminated by external or internal shock,
- •or incessant VT lasting >30 minutes,
- •or very frequent nonsustained or sustained VT leading to hemodynamic instability with the need of escalation of the therapy
- •clinical indication for LBGS based on the judgment of the physician, independent of the study
排除标准
- •known allergy to bupivacaine
- •prior LBGS performed <7 days before the study
- •known reversible provoking trigger of the arrhythmias
- •ventricular arrhythmias triggered by premature ectopic beats during bradycardia
- •hemodynamically tolerated idiopathic VT in patients without structural heart disease
结局指标
主要结局
Change in the number of episodes of sustained VT/VF
时间窗: 2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)
Change by \>50% of the number of episodes of sustained ventricular tachycardia/fibrillation compared to 24 hours before LGSB, without escalation of antiarrhythmic therapy during 24 hours after LGSB (deep sedation requiring mechanical ventilation, addition of another antiarrhythmic drug, implantation of mechanical circulatory support, unplanned emergent catheter ablation)
Change in arrhythmia burden quantified by Holter ECG
时间窗: 2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)
Change of the percent of QRS complexes with ventricular tachycardia by \>50% on Holter ECG, as compared to 24 hours before LGSB, without escalation of antiarrhythmic therapy during 24 hours after LGSB (deep sedation requiring mechanical ventilation, addition of another antiarrhythmic drug, implantation of mechanical circulatory support, unplanned emergent catheter ablation).
次要结局
未报告次要终点
研究者
Marek Sramko, MD, PhD
Head of the Department of Acute Cardiology
Institute for Clinical and Experimental Medicine