The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Persistent Atrial Fibrillation
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
- 否
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
Patients randomized to external cardioversion will undergo external synchronized cardioversion per institutional protocol.
干预措施: Internal Cardioversion (Procedure)
External Cardioversion
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
Samy C Elayi, MD
Assistant Professor
University of Kentucky
