EU Focal Impulse and Rotor Modulation Registry -Topera E-FIRM Registry-
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 9
- 主要终点
- Number of Participants With 12-Month Success
研究概览
简要总结
This is a registry to assess the safety and effectiveness of FIRM guided procedures for the treatment of symptomatic any type of atrial fibrillation.
FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors identified by the FIRMap® basket catheter for visualising of rotors with the RhythmView® mapping system. In addition to the FIRM guided ablation any other ablation method could be applied.The acute success of FIRM ablations is defined as elimination of rotors defined by absence of rotors.
Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.
详细描述
Prospective and retrospective enrollment is possible.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •reported incidence of at least 2 documented episodes of symptomatic AF (paroxysmal, persistent or long standing persistent) during the 3 months preceding the initial AF ablation attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping medication
排除标准
- •women who are pregnant
- •As this is a registry only data of patients will be included who have been treated according to the current AF guidelines.
结局指标
主要结局
Number of Participants With 12-Month Success
时间窗: 12-months after index procedure
Single procedure freedom from atrial fibrillation recurrence
Number of Participants With Acute Success
时间窗: day of procedure
Acute Success was defined as the elimination (by ablation) of all identified rotors
Number of Participants With Acute Safety Success
时间窗: 7 days after index procedure
Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure
Number of Participants With 12-Month Safety Success
时间窗: 12-months after index procedure
Success was defined as freedom from Serious Adverse Events at 12-months after index procedure
次要结局
未报告次要终点