Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea
2016年10月24日 更新者：Malcolm Kohler、University of Zurich
Electroanatomic Origin of Premature Atrial Beats in Patients With Paroxysmal Atrial Fibrillation Induced by Intra-thoracic Pressure Swings Simulating Obstructive Sleep Apnea
There is accumulating evidence for obstructive sleep apnea (OSA) as an independent risk factor for paroxysmal atrial fibrillation and for high recurrence rates of atrial fibrillation after ablation therapy.
We have previously shown that simulated OSA triggers premature atrial beats (PABs) by acute changes in intra-thoracic pressure.
Most episodes of atrial fibrillation are initiated by PABs.
However, the origin of PABs induced by intra-thoracic pressure swings is unknown.
This study investigates the origin of premature atrial beats induced by intra-thoracic pressure changes that simulate obstructive sleep apnea in patients with atrial fibrillation.
研究概览
研究类型
介入性
注册 (实际的)
2
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
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Canton of Zurich
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Zurich、Canton of Zurich、瑞士、8091
- University Hospital of Zurich
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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
18年 至 75年 (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:
- History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm
- Scheduled for circumferential pulmonary venous isolation treatment
- 18 to 75 years of age
- Signed informed consent
Exclusion Criteria:
- Treated with class III anti-arrhythmic agents (at the moment of pulmonary venous isolation)
- Treated for obstructive sleep apnea
- Previous catheter ablation in the pulmonary veins or left atrium
- Severe structural heart disease
- Mental or physical disability precluding informed consent or compliance with the protocol
- Enrolled in another study that would confound the results of this trial
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：基础科学
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Pulmonary vein isolation
Intra-thoracic pressure swings induced by breathing manoeuvres during standard catheter-ablation procedure.
Catheter-based electrical mapping and pressure in the left atrium and pulmonary veins during standard catheter-ablation procedure.
Only patients with an apnea-hypopnea index > 5/h and documented premature atrial beats during the Mueller manoeuvre will be eligible for the catheter-based electrical mapping.
Follow-up after 1 year for atrial fibrillation recurrence.
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The MM will be carried out during a elective standard pulmonary vein isolation procedure.
The MM will be performed using an occluded mouthpiece with a small air leak to prevent complete closure of the glottis during inspiration and thus assure negative pressure throughout the entire airway.
After expiration, inspiration with a target negative intrathoracic pressure of -40mmHg will be carried out against the mouthpiece.
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无干预：No intevention
Intra-thoracic pressure swings induced by breathing manoeuvres during ECG-monitoring.
Only patients with an apnea-hypopnea index < 5/h and no premature atrial beats during the Mueller manoeuvre will be assigned to the no intervention arm.
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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 |
|---|---|---|
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Electroanatomical origin of premature atrial beats
大体时间：Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
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(Loop-)Catheter-based origin detection in patients with apnea-hypopnea index > 5/h in home sleep study and documented premature atrial beats during three time points: baseline (normal breathing), inspiration through a threshold load device, and the Mueller Manoeuvre (MM).
Origins will be quantitatively marked at a left atrial map.
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Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Catheter-based pressure in the left atrium and pulmonary veins during intra-thoracic pressure changes
大体时间：Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
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Catheter-based left atrial pressure measurement in patients with apnea-hypopnea index > 5/h in home sleep study and documented premature atrial beats during three time points: baseline (normal breathing), inspiration through a threshold load device, and the Mueller Manoeuvre.
Changes in left atrial pressure will be recorded in cmH2O.
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Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
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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：Malcolm Kohler, MD, Prof、University of Zurich
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
2014年9月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2016年1月1日
研究注册日期
首次提交
2014年10月14日
首先提交符合 QC 标准的
2014年10月20日
首次发布 (估计)
2014年10月21日
研究记录更新
最后更新发布 (估计)
2016年10月25日
上次提交的符合 QC 标准的更新
2016年10月24日
最后验证
2016年10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.