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Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation: A Safety and Feasibility Study (LEIO-AF)

The Safety and Feasibility of Concomitant Left Atrial Appendage Electrical Isolation and Occlusion in the Treatment of Persistent Atrial Fibrillation

Atrial fibrillation (AF) affects as many as 1 in 16 people over the age of 65 and reduces the quality of life of large numbers of people in the UK and around the world. Catheter ablation is a minimally invasive treatment that has been developed to help eliminate AF. Recent studies have identified that a particular area of the heart, namely the left atrial appendage (LAA), which is a pouch in the left atrium (small collecting chamber of the heart), may be the main source of AF in many cases. There is a clear lack of knowledge about the structure, anatomy, function and electrical properties of the LAA, which is fundamental to furthering our understanding and management of AF.

In addition, it is well known that AF significantly increases the risk of stroke. The majority of strokes occur due to blood clots forming in the LAA. Traditionally, the most effective treatment to minimise the risk of stroke has been to thin the blood with agents such as warfarin. This therapy requires regular blood tests at much inconvenience to patients and increases the risk of bleeding complications. Recently, a large study demonstrated that use of an implanted device (Watchman®) to occlude the LAA is as effective as warfarin in preventing stroke and confers a lower mortality rate.

We aim to investigate whether it is safe and feasible to ablate the LAA and to implant a Watchman® device during the same procedure in patients who are in atrial fibrillation all of the time.

研究概览

详细说明

While catheter ablation has revolutionized the treatment of atrial fibrillation (AF), the long-term outcomes in treating persistent AF are variable, often requiring more than one procedure to maintain long-term freedom from AF. Electrical isolation of the pulmonary veins (PVs) is central to catheter ablation strategies, with the majority of paroxysmal AF recurrences being associated with reconnection of previously isolated PVs. Persistent AF is different, with recurrences being attributable to foci and or substrate outside the PVs, including the left atrial appendage (LAA). Recently, a non-randomised, consecutive study of 987 patients undergoing repeat catheter ablation for persistent (82%) and paroxysmal (18%) AF has demonstrated that almost 30% of recurrences were due to an LAA focus and that the addition of LAA electrical isolation to a standard persistent AF ablation strategy improves freedom from AF.

Percutaneous LAA occlusion has been demonstrated to be as effective as warfarin in reducing the risk of thromboembolic stroke in patients with AF. The combination of a standard AF ablation lesion set with LAA electrical isolation and LAA occlusion may be an elegant method of improving success rates of ablation for persistent AF whilst also mitigating stroke risk and reducing the bleeding risks from long-term anticoagulation. However, the feasibility and safety of concomitant endocardial electrical isolation and mechanical occlusion of the LAA is not known.

In this study we test the hypothesis that concomitant electrical isolation of the LAA and its occlusion with a Watchman device, following a standard persistent AF lesion set is feasible and safe.

研究类型

介入性

注册 (预期的)

20

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

    • Greater London
      • London、Greater London、英国、SW3 6NP
        • Royal Brompton & Harefield NHS Foundation Trust

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 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 18 - 80 years
  • Symptomatic, documented AF lasting for at least 7 days (persistent or permanent AF) refractory to at least 1 AAD and/or DCCV
  • Long-term indication to continue warfarin

Exclusion Criteria:

  • Previous ablation procedure
  • Pregnancy
  • Prior AV nodal ablation or complete heart block (CHB) with a permanent pacemaker (PPM)
  • Contraindication to anticoagulation
  • Persistent thrombus in the left atrium despite anticoagulation
  • Active malignancy
  • Expected life expectancy < 6 months
  • Cerebrovascular accident within the previous 6 months
  • Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
  • Cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), valve or coronary bypass surgery within the previous 3 months
  • Prior left atrial catheter ablation with the intention to treat AF
  • Prior surgical interventions for AF such as the MAZE procedure
  • Previous heart transplant
  • Severe neuro-muscular disease
  • Creatinine clearance <30 ml/min (estimated GFR)
  • Current participation in another research study
  • Unable to understand and comply with protocol or to give written informed consent
  • Contraindication to general anaesthesia

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:不适用
  • 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
实验性的:LAA electrical isolation + occlusion
Standard persistent AF ablation protocol + LAA electrical isolation + Watchman device implantation to occlude LAA
LAA electrical isolation + Watchman device implantation to occlude LAA

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
Feasibility of concomitant LAA electrical isolation and percutaneous left atrial appendage occlusion using Watchman® device in patients with persistent atrial fibrillation
大体时间:At time of procedure
Success rates of LAA electrical isolation and Watchman® device implantation post-LAA isolation will be determined during index procedures
At time of procedure
Freedom from serious adverse events (stroke, myocardial infarction, emergency surgery, death) immediately after the procedure and during follow-up
大体时间:Immediately after the procedure and at 6 months
Serious adverse event rate will be determined immediately after the procedure and during the 6 month follow-up period
Immediately after the procedure and at 6 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:Tom Wong, MD、Royal Brompton & Harefield NHS Foundation 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

2013年7月1日

初级完成 (预期的)

2014年10月1日

研究完成 (预期的)

2014年10月1日

研究注册日期

首次提交

2014年1月3日

首先提交符合 QC 标准的

2014年1月3日

首次发布 (估计)

2014年1月6日

研究记录更新

最后更新发布 (估计)

2014年6月3日

上次提交的符合 QC 标准的更新

2014年6月2日

最后验证

2014年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2012CI004B, 12/LO/0809
  • 94318 (其他标识符:NIHR CSP)

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.

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