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临床试验/NCT02245009
NCT02245009Unknown不适用

Safety of External Electrocardioversion in Device Patients - the SEED Registry

Universitätsklinikum Köln1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Composite safety endpoint: Changes of lead and device parameters

研究概览

简要总结

Arrhythmias of the atria of the heart are a common comorbidity in patients with cardiac rhythm management devices, such as pacemakers and implantable cardioverter/defibrillators (ICD). External electrical cardioversion is an established method to achieve rhythm control (restore normal sinus rhythm) in patients with atrial arrhythmia. Little data on safety and efficacy of external electrical cardioversion in patients with cardiac rhythm management devices exists. Thus, available data on the safety of external electrical cardioversion in cardiac rhythm management patients lacks statistical power to accurately reflect the true hazard of external electrical cardioversion in patients with cardiac rhythm management devices.

The aim is to systematically include and follow all patients with cardiac rhythm management devices presenting for external electrical cardioversion, to analyse the effects of external electrical cardioversion on leads and devices.

详细描述

Introduction Atrial arrhythmias are a common comorbidity in patients with cardiac rhythm management (CRM) devices, such as pacemakers and ICD. External electrical cardioversion is an established method to achieve rhythm control in patients with atrial arrhythmia. A paucity of data on safety and efficacy of external electrical cardioversion in patients with cardiac rhythm management devices exists. Most publications are of older date and predominantly case reports or case collections. Few prospective studies with a population of cardiac rhythm management patients after external electrical cardioversion have been published in recent years.

Thus, available data on the safety of external electrical cardioversion in cardiac rhythm management patients lacks statistical power to accurately reflect the true hazard of external electrical cardioversion in patients with cardiac rhythm management devices.

Rationale Electrocardioversion in Propofol sedation for atrial or ventricular tachyarrhythmia is an established therapy. It is routinely used for patients with cardiac rhythm management devices and the risk of device and lead affectation is deemed to be low. This assumption is currently not supported by substantial and current scientific data, mostly relying on older reports. No large, prospective trials with a population of patients with modern cardiac rhythm management devices exists.

Aim of the study The aim is to systematically include and follow all patients with cardiac rhythm management devices presenting for external electrical cardioversion, to analyse the effects of external electrical cardioversion on leads and devices. Thereby, providing reliable evidence and detecting possible SAE with a low incidence. Furthermore, to gather information on efficacy and recurrence rate in this population, to examine the value of external electrical cardioversion for rhythm control in these patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Informed, written consent
  • Atrial or ventricular arrhythmia with indication for CV
  • Status post CRM implantation, including CRT-D

排除标准

  • Age < 18 years
  • Patients under guardianship or with mental disorders / disabilities
  • lead implantation < 4 weeks prior to CV
  • contraindications for eCV or transoesophageal echocardiographie (TOE)

结局指标

主要结局

Composite safety endpoint: Changes of lead and device parameters

时间窗: 2 weeks after CV

assessed by device interrogation, if any of the following criteria is met: * a rise in threshold (at constant pulse duration) of \>1V * exit block of any of the pacing leads * loss of programming of the device * rise in shock impedance by 50% * rise in charge time by 50% * drop in battery voltage of ≥0.2V within \< 6 weeks

次要结局

  • Loss of programming(within 15 minutes after CV)
  • Efficacy Endpoint(within 15 minutes after CV)
  • Late changes of lead parameters(2 weeks after CV)
  • Inadvertent induction of ventricular fibrillation(10 seconds after CV)
  • Composite endpoint: Early lead changes(within 15 minutes after CV)
  • Change of shock impedance(within 15 minutes after CV)
  • Change of charge time(within 15 minutes after CV)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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