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临床试验/NCT03164395
NCT03164395已完成不适用

The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Persistent Atrial Fibrillation

University of Kentucky2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Acute Conversion of Atrial Fibrillation to Sinus Rhythm

研究概览

简要总结

This study seeks to determine the efficacy of single coil defibrillation leads for cardioversion of persistent atrial fibrillation.

详细描述

This study seeks to compare the efficacy of single coil defibrillation leads for the internal cardioversion of atrial fibrillation as compared with cardioversion by external defibrillation pads. It is known that dual coil leads are effective for atrial cardioversion, but the presence of the SVC defibrillation coil allows for selection of shock vector that more reliably incorporates the majority of atrial tissue compared to a single right ventricular lead. For a variety of reasons single coil defibrillation leads are now implanted in the majority of patients requiring placement of implantable cardiac defibrillators, and many of these patient's will later develop atrial fibrillation and potentially require cardioversion. Currently, there is no clear consensus on how to approach cardioversion in these patient's and both external and internal methods are used. Internal cardioversion may be ineffective exposing patient's unnecessarily to repeated shocks and battery depletion. External cardioversion may carry a small risk of damaged to the CIED.

The investigator's goal is to identify patient's referred for cardioversion for atrial fibrillation who also have an implanted cardiac defibrillator with a single coil defibrillation lead and randomize them to either external or internal cardioversion.

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
None

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

  • greater than 18 years of age
  • persistent atrial fibrillation and have been recommended by your primary cardiologist to undergo cardioversion
  • have an implantable cardiac defibrillator

排除标准

  • over the age of 99

研究组 & 干预措施

Internal Cardioversion

Experimental

Patients randomized to external cardioversion will undergo external synchronized cardioversion per institutional protocol.

干预措施: Internal Cardioversion (Procedure)

External Cardioversion

Active Comparator

Patients randomized to internal cardioversion will have a maximum energy shock delivered from the device between the RV coil and can. If cardioversion is not successful they will then undergo external cardioversion per institutional protocol.

干预措施: External Cardioversion (Procedure)

结局指标

主要结局

Acute Conversion of Atrial Fibrillation to Sinus Rhythm

时间窗: Immediate

Does the patient return for at least one beat to sinus rhythm following the administration of a shock

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samy C Elayi, MD

Assistant Professor

University of Kentucky

研究点 (2)

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