Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP (LAAPITUP)
2010年3月29日 更新者：Eastbourne General Hospital
The purpose of this study is 3 fold:-
- To compare the efficacy and complication rates of 2 widely used methods, conventional irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of AF ablation for PAF.
- To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter.
- To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF ablation therapy for PAF.
研究概览
地位
未知
条件
研究类型
介入性
注册 (预期的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
East Sussex
-
Eastbourne、East Sussex、英国、BN21 2UD
- Eastbourne District General Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 至 80年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patient aged 16-80 years old.
- Symptomatic PAF with AF episodes self terminating after at least 30 seconds but not longer than 24 hours. Preference is given to patients with AF episodes lasting no longer than 4 hours.
- PAF should have failed at least one drug therapy medical therapy.
- Patients must give written informed consent form prior to participating in this study.
Exclusion Criteria:
- Patient is suffering with unstable angina in last 1 week.
- Patient has had a myocardial infarction within last 2 months.
- Patient is expecting or has had major cardiac surgery within last 2 months.
- Patient is participating in a conflicting study.
- Patient is mentally incapacitated and cannot consent or comply with follow-up.
- Patient has NYHA class III/ IV heart failure.
- Patients with severe valvular or ventricular dysfunction.
- Pregnancy.
- Patient suffers with other cardiac rhythm disorders.
- Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Ablation Frontiers Ablation
This group will undergo AF ablation using Ablation Frontiers Technology.
|
AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC.
|
|
有源比较器：LASSO ablation
This group will undergo atrial fibrillation ablation with traditional LASSO technology
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AF Ablation with traditional LASSO catheter
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|
有源比较器：Reveal XT monitoring
This group will be monitored pre and post ablation using a Reveal XT implantable loop recorder.
|
Reveal XT implantable loop recorder monitored group
|
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有源比较器：Permanent Pacemaker - dual chamber
This group will be monitored pre and post ablation with a dual chamber permanent pacemaker
|
This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.
|
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 |
|---|---|---|
|
AF Burden
大体时间：12 Months
|
AF Burden post left atrial ablation is defined as the sum of the duration of all atrial tachyarrhythmias expressed as a percentage of the total observation period as assessed by PM Holters.
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12 Months
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AF Burden
大体时间：12 months
|
Comparison of AF burden post PVI ablation using a conventional irrigation tip catheter with LASSO guidance (or equivalent) versus Ablation Frontiers Technology using the PVAC, MASC and TVAC catheters via standard trans-septal techniques.
|
12 months
|
|
AF Burden detected
大体时间：12 months
|
To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter.
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Arrhythmia frequency - symptomatic or asymptomatic.
大体时间：12 months
|
Arrhythmia Frequency is defined as the total number of atrial tachyarrhythmic episodes divided by the observation period, expressed as episodes per day as assessed by PM Holters.
|
12 months
|
|
Time to first episode of AF
大体时间：12 months
|
Time to persistent AF is defined as the time from ablation to the first recorded episode of AF
|
12 months
|
|
Average AF duration
大体时间：12 months
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Average arrhythmia duration is defined as the total duration of atrial arrhythmia divided by the total number of atrial arrhythmia episodes.
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12 months
|
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Time to persistent AF.
大体时间：12 months
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Time to persistent AF (atrial fibrillation episode lasting for 7 days)
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12 months
|
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Average SR duration.
大体时间：12 months
|
Average sinus rhythm duration is defined as the total duration of sinus rhythm from first atrial arrhythmic episode until last atrial arrhythmic episode divided by the number of atrial arrhythmic episodes minus 1.
|
12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Stephen S Furniss, FRCP, MD、East Sussex NHS Trust
- 首席研究员：AN Sulke, FRCP, MD、East Sussex NHS Trust
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年4月1日
初级完成 (预期的)
2012年4月1日
研究完成 (预期的)
2012年11月1日
研究注册日期
首次提交
2010年3月29日
首先提交符合 QC 标准的
2010年3月29日
首次发布 (估计)
2010年3月30日
研究记录更新
最后更新发布 (估计)
2010年3月30日
上次提交的符合 QC 标准的更新
2010年3月29日
最后验证
2010年3月1日
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.