2024-520387-34-00撤回4 期
A multicentre randomised study on percutaneous stellate ganglion block as first line treatment in patients with electrical storm: the STAR 2 study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 180
- 试验地点
- 13
- 主要终点
- 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
研究概览
简要总结
The primary objective of the STAR 2 study is to assess if the efficacy of PSGB, expressed as the number of patients with complete suppression of treated VA (with ATP, internal DC shock or external DC shock) during the first three hours after treatment, is superior to amiodarone, considered the standard of care.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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
- •Known allergy or hypersensitivity or previous idiosyncrasy to amiodarone, lidocaine, bupivacaine or to other anesthetics allowed in the study
- •Other contraindications to amiodarone administration (e.g. QT prolongation, LQT syndrome, severe bradycardia, second or third degree atrio-ventricular block)
- •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
- •Active enrollment in another pharmacological study
结局指标
主要结局
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
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
未报告次要终点
研究者
Simone Savastano
Scientific
Fondazione IRCCS Policlinico San Matteo
研究点 (13)
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