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临床试验/NCT07375264
NCT07375264
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Long-term Outcomes of Ultrasound-guided Percutaneous Bilateral Cardiac Sympathetic Denervation in Patients With Refractory Arrhythmic Storm: a Single-center Case Series

Jose Manuel López González1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年4月11日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Jose Manuel López González
入组人数
18
试验地点
1
主要终点
Arrhythmic burden.

概览

简要总结

The objective of our study was to evaluate the effectiveness of stellate ganglion block (SGB) and of the bilateral cardiac sympathetic denervation (BCSD) in patients with electrical storm refractory to conventional treatment..

详细描述

A prospective, single-center observational study was designed with the aim of evaluate the safety and short-term efficacy of SGB within the first 24 hours, as well as the long-term effectiveness of ultrasound-guided percutaneous BCSD at 12 months, in patients with refractory electrical storm.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • patients over 18 years of age.
  • arrhythmic storm refractory to conventional treatment.

排除标准

  • patients younger than 18 years of age.
  • previous history of heart transplantation.
  • history of previous surgical cardiac sympathetic denervation.
  • patients with neck anatomy considered unsuitable for the procedure (including previous neck surgery, burns, the presence of extensive scars, or large goiters with significant displacement of adjacent structures).
  • contraindications to the interventional technique (such as infection at the puncture site, or refusal to provide consent).

研究组 & 干预措施

SGB + BCSD.

Patients with arrhythmic storm refractory to conservative medical treatment undergoing stellate ganglion block (SGB) and bilateral cardiac sympathetic denervation (BCSD) for arrhythmic storm control.

干预措施: Cardiac sympathetic denervation. (Procedure)

结局指标

主要结局

Arrhythmic burden.

时间窗: The arrhythmic burden was assessed both in the early period (first 24 hours following SGB) and in the long term (during the 12 months following BCSD).

The arrhythmic burden was quantified by the number of sustained ventricular arrhythmias, antitachycardia pacing (ATP) therapies, and ICD (implantable cardioverter-defibrillator) shocks recorded during the follow-up period.

次要结局

未报告次要终点

研究者

发起方
Jose Manuel López González
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jose Manuel López González

MD. Consultant Anesthesiologist and Pain Physician

Fundación para la Investigación Biosanitaria del Principado de Asturias

研究点 (1)

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