Topera C-FIRM Registry
Control for EU (European Union) Focal Impulse and Rotor Modulation Registry - Topera C-FIRM Registry-
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.
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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Berlin、德国、12683
- Unfallkrankenhaus Berlin
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Baden-Würtemberg
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Karlsruhe、Baden-Würtemberg、德国、76133
- Städtisches Klinikum Karlsruhe GmbH
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Bayern
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Bad Neustadt An Der Saale、Bayern、德国、97616
- Herz- und Gefäßklinik
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Coburg、Bayern、德国、96450
- Klinikum Coburg GmbH
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Brandenburg
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Potsdam、Brandenburg、德国、14471
- Kardiologische Gemeinschaftspraxis am Park Sanssouci
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NRW
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Bad Oeynhausen、NRW、德国、32545
- Herz- und Diabeteszentrum NRW
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Sachsen
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Dresden、Sachsen、德国、01099
- Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
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Leipzig、Sachsen、德国、04289
- Herzzentrum Leipzig
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Rotterdam、荷兰、3015
- Erasmus Medical Center
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：其他
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Acute Success
大体时间：day of procedure
|
Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure
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day of procedure
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Number of Participants With 12-Month Effectiveness
大体时间：12 months after initial AF ablation
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Effectiveness success was defined as single procedure freedom from AF recurrence at 12-months after index procedure, excluding a 3-month blanking period.
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12 months after initial AF ablation
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Number of Participants With Acute Safety Success
大体时间：7 days after initial AF ablation
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Acute safety success was defined as freedom from Serious Adverse Events 7 days after initial AF ablation
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7 days after initial AF ablation
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Number of Participants With 12-Month Safety Success
大体时间：12-months after index procedure
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12-Month safety success was defined as freedom from Serious Averse Events at 12-months after index procedure
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12-months after index procedure
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With 6-month Safety Success
大体时间：6-months after index procedure
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6-Month safety success was defined as freedom from Serious Adverse Events 6-months after index procedure
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6-months after index procedure
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合作者和调查者
合作者
调查人员
- 首席研究员：Gerhard Hindricks, Prof. Dr.、Herzzentrum Leipzig - Universitätsklinik
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.