Safety, Radiation Exposure and Efficacy of Remote MAGNetic Catheter Ablation for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 804
- 试验地点
- 1
- 主要终点
- Safety: peri-procedural major complications.
研究概览
简要总结
Prospective observational single center trial, evaluating the safety, radiation exposure and efficacy of remote magnetic catheter ablation for atrial fibrillation in daily routine.
详细描述
Background: Since the first description in 1998 catheter-interventional ablation (CA) has evolved to a standard treatment for symptomatic drug-refractory atrial fibrillation (AF).
Ablation efficacy but also complication percentage and radiation exposure are influenced by several factors, among them patient age, body weight, type and duration of AF, underling cardiac disease as well as the used ablation method, technology and the experience of the operator.
The objectives of developing a system for remote magnetic catheter navigation (RMN) were to improve the efficacy and safety of complex ablation procedures and to reduce radiation exposure. However, convincing data supporting this theory are still lacking.
Aim: To evaluate efficacy, safety profile / complication rate and radiation exposure in serial ablation procedures for paroxysmal and persistent AF as well as repeat interventions based on remote magnetic navigation and 3-D image integration with assessment of the learning curve for this complex technology.
Design: single center observational registry, analytical questioning, non-randomized, non-controlled, not blinded, consecutive patient inclusion
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Consecutive patients with class I or class IIa indication for catheter ablation for symptomatic atrial fibrillation according to the current guidelines.
排除标准
- •Contraindication for AF catheter ablation
- •Contraindication for magnetically guided ablation procedure
- •Age < 18 years, gravidity, breast feeding
结局指标
主要结局
Safety: peri-procedural major complications.
时间窗: Peri-procedural (from the beginning of the procedure until 48 hours after sheath removal)
Procedure associated adverse events are classified according to the 2012 Expert consensus statement on catheter and surgical ablation of AF \[Calkins et al, Europace 2012\].
次要结局
- Acute efficacy: number of successfully isolated pulmonary veins.(Intra-procedural)
- Long-term efficacy: freedom from atrial tachyarrhythmia.(12 months)
- Long-term efficacy: time to recurrence of atrial tachyarrhythmia.(12 months)
- Safety: radiation exposure.(Peri-procedural (from the beginning of the procedure until sheath removal))
- Safety: incidence of procedure related adverse events during long term follow-up.(12 months)
- Safety: peri-procedural minor complications.(Peri-procedural (from the beginning of the procedure until 48 hours after sheath removal))
研究者
Dr. Dirk Bastian
Principle investigator
Paracelsus Medical University