Control for EU (European Union) Focal Impulse and Rotor Modulation Registry - Topera C-FIRM Registry-
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 9
- 主要终点
- Number of Participants With Acute Success
研究概览
简要总结
This is a control registry to the E-FIRM registry to track conventional atrial fibrillation (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for the treatment of symptomatic atrial fibrillation. Conventional AF ablation is defined as pulmonary vein isolation (PVI) and any additional ablation for AF according to the standard routine of the center.
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 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 and the daily routine of the center.
结局指标
主要结局
Number of Participants With Acute Success
时间窗: day of procedure
Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure
Number of Participants With 12-Month Safety Success
时间窗: 12-months after index procedure
12-Month safety success was defined as freedom from Serious Averse Events at 12-months after index procedure
Number of Participants With 12-Month Effectiveness
时间窗: 12 months after initial AF ablation
Effectiveness success was defined as single procedure freedom from AF recurrence at 12-months after index procedure, excluding a 3-month blanking period.
Number of Participants With Acute Safety Success
时间窗: 7 days after initial AF ablation
Acute safety success was defined as freedom from Serious Adverse Events 7 days after initial AF ablation
次要结局
未报告次要终点