A Nonrandomized Observertionel Study That Will Show the Utility and the Safety by Using the Remote Magnetic Navigation of Ablationcatheters and the Stereotaxis Equipment
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Clinical effect and safety of ablation
研究概览
简要总结
Patients with several heart arrythmia can potentially be cured by catheterablation. For some arrythmias 95% of the patients are cured. Also patients with atrial fibrillation are cured by catherablation even though the effect is not as impressive as for other cardiac arrythmias. About 70% of patients with paroxystic and persistant atrial fibrillation are cured. Most of the remaining obtain a reduction of their symptoms.
At conventional ablation of atrial fibrillation the catheters are manually navigated to the ideal anatomic position where to isolate the pulmonary veins from the left atrium.
Lately it has been possible to navigate the ablationcatheters using 'remote magnetic navigation' using a magnetic based navigation equipment, Stereotaxis.
The Heartcentre of Rigshospitalet had this Stereotaxis equipment installed in the autumn of 2006.
We will investigate the utility and safety of using this remote magnetic navigation/Stereotaxis.
详细描述
The purpose on this study is to show the utility and the safety by using the remote magnetic navigation of ablation catheters with the Stereotaxis equipment at ablations of
- atrial fibrillation, atrial flutter and other arrythmias
- childrens arrythmias
- arrythmias of patients with pacemaker or ICD (Implantable Cardiac Defibrillator)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •following patients that need catheter ablation:
- •Patients with atrial fibrillation
- •Patients with artial flutter
- •Patients with other tachy arrythmia
- •Patients with paceaker/ICD
排除标准
- •Patients with anamnestic psycosis or other conditions where information is impossible or insure to give
- •Contraindication to magnetic ablation therapy
结局指标
主要结局
Clinical effect and safety of ablation
时间窗: 3 month after procedure
Stroke and death
次要结局
- Feasibility of remote navigation(within 3 months)