Relationship Between Catheter Contact Force and Electrogram Characteristics in Fibrillating Human Atrial Myocardium
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Electrogram characteristics
研究概览
简要总结
Until recently, there was no way of telling how firmly the tip of the catheter was in contact with the heart and how this contact was orientated. The electrical signals measured through the catheters, known as electrograms, are used to guide the sites and duration of ablation, but the effect of catheter contact and orientation on these signals in human heart muscle that is fibrillating is not known. New catheters have now been developed which can measure the force of contact at their tip: using these, the investigators will examine how contact force affects the electrical behaviour of heart muscle tissue in atrial fibrillation. The effect the force of contact has on the electrogram recorded will also be investigated. In so doing we hope to gain a better understanding of the relationship between tissue contact and the electrograms we measure and in so doing improve the safety and effectiveness of ablation procedures.
Hypothesis: Catheter contact force and orientation have a significant impact on the characteristics of bipolar electrograms in the fibrillating human atrium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Persistent or paroxysmal atrial fibrillation
- •Listed for ablation of atrial fibrillation on clinical grounds
排除标准
- •Contraindication to catheter ablation
- •Contraindication to anticoagulation
- •Contraindication to TOE
研究组 & 干预措施
Constant Catheter Contact Force
No alteration of catheter contact force during recording period
干预措施: THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow) (Device)
Variable catheter contact force
change in contact force from low to high after 30seconds of recording.
干预措施: THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow) (Device)
结局指标
主要结局
Electrogram characteristics
时间窗: Baseline and 30 seconds
Effect of changes in contact force and orientation on: slew rate, local mean cycle length, electrogram complexity and fractionation index, dominant frequency, organisation index, CFAE grade, interval confidence level, shortest complex interval and average complex interval
次要结局
- Ablation Power (Watts)(Baseline and 30 seconds)
- Electrogram amplitude(Baseline and 30 seconds)
- Electrogram responses to ablation(Baseline and 30 seconds)
- Electrogram Contact Mapping(During Study)