A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs Lifepak)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 546
- 试验地点
- 2
- 主要终点
- The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock
研究概览
简要总结
The goal of this single center, investigator initiated, open label prospective randomized controlled trial is to compare the efficacy of a single 200J RBW shock and a single 360J BTE shock. The secondary objective of the study is to compare the frequency of adverse events after one or two 200J RBW or 360J BTE shocks
详细描述
Data will be derived from approximately 560 patients arriving to Inova sites of care in Atrial Fibrillation (AF) scheduled to undergo either Atrial Fibrillation ablation with expected Direct Current Cardioversion (DCCV) or elective stand-alone AF DCCV. Patients will be included if they are in AF prior to their procedure and are willing to sign the information sheet and comply with the research procedures. Participants will be excluded if they are in a rhythm other than AF on arrival, have not been appropriately anticoagulated with warfarin or direct oral anticoagulant, or have known left atrial appendage thrombus prior to their procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •In AF on presentation with plan for DCCV in either the Electrophysiology lab or DCCV procedure area
排除标准
- •Participants who are receiving any other investigational agents.
- •Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- •Patients with arrhythmias other than AF
- •Patients with hemodynamically unstable AF
- •Patients with untreated hyperthyroidism
- •Patients with known or suspected pregnancy
- •Patients without sufficient anticoagulation or a transesophageal echocardiogram or computed tomography scan documenting the absence of intracardiac thrombi
结局指标
主要结局
The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock
时间窗: At least 1 minute after shock delivery
The frequency of NSR by ECG one minute after a single full output DCCV shock is delivered by either a 200J RBW waveform shock from a Zoll Series R defibrillator or 360J BTE waveform shock from a Lifepak 15 defibrillator
次要结局
- The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First or Second DCCV Shock(At least 1 minute after shock delivery)
- The Frequency of NSR One Minute After the First or Second Full Output DCCV Shock is Delivered by a Zoll Series R RBW Waveform Defibrillator and a Lifepak Series 15/20 BTE Waveform Defibrillator After Crossing Over From the Alternative Defibrillator.(At least 1 minute after shock delivery)