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Surgical vs Percutaneous LAAO

2022年9月19日 更新者:Professor Bryan Ping Yen YAN、Chinese University of Hong Kong

A Study on Outcomes of Surgical and Percutaneous Left Atrial Appendage Closure

Atrial fibrillation is the most common cardiac arrythmia globally. Its prevalence ranges between 2-4% worldwide. It is associated with significant morbidity and mortality. One of the main concerns of AF is the risk of thromboembolism, which can result in debilitating or detrimental stroke. The gold standard for preventing AF stroke is long term oral anticoagulation in the form of warfarin or NOAC1,2.

Around 50% of patients who need anticoagulation are not on any form tablets and about 5% of patients who are not anticoagulated developed stroke. Some patients could not take anticoagulation because of high risk of bleeding, and this result in challenges within this cohort of patients. The left atrial appendage (LAA) is believed to be the main source of embolic in atrial fibrillation. The LAA is an anterolateral structure which is the smallest part of the left atrium. It originates anterior from the left pulmonary vein ostium. More than 90% of thromboembolic events happened in the LAA of non-rheumatic patients whereas only 57% of thrombi in rheumatic mitral valve disease3. This suggests that occluding the LAA is more beneficial in the non-valvular AF patients. Incomplete LAA closure is associated with a higher occurrence of thromboembolism. The growing evidence of LAA occlusion has been emerged. Percutaneous LAA Occlusion (LAAO) has been suggested that it may be considered for stroke prevention in patients with atrial fibrillation and contraindication for long term anticoagulation (class IIB, level B)1,2. This recommendation is based on the randomized controlled trials to show that percutaneous devices are non-inferior to oral anticoagulation in terms of preventing stroke in AF patients.

Surgical LAA clip occlusion (LAAC) has emerged as a potential method to isolate LAA to prevent thromboembolism. The recent LAAOS III trial shows that the risk of ischemic stroke or systemic embolism was lower with concomitant left atrial appendage occlusion performed during the surgery than without it, most of whom continued to receive ongoing anticoagulant therapy4. This reinforced the mechanistic value of occluding the LAA in prevention of stroke. However, the efficacy of isolated LAAC without anticoagulation is uncertain. Besides, as this surgical clip occlusion is frequently performed together with other concomitant cardiac surgery, post evaluation in the form of imaging is lacking. Our study aims to study the imaging follow-up result and clinical efficacy of surgical and percutaneous left atrial appendage closure.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (预期的)

260

阶段

  • 不适用

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

19年 及以上 (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:

  • Atrial fibrillation diagnosis
  • Underwent LAA clip (Atriclip) or left atrial appendage occlusion with CHADVASC >=2

Exclusion Criteria:

  • Subject not required anticoagulation due to low CHADVASC
  • Mechanical valve replacement
  • Tissue mitral valve replacement or tissue aortic valve replacement with underlying chronic rheumatic heart disease

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:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Left Atrial Appendage Occlusion
有源比较器:Left Atrial Appendage Closure,
Patients in the surgical arm (LAAC) will be arranged to do TEE, which is not considered standard of care.

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
occlusion result
大体时间:around 1 year post procedure
to compare the occlusion result of LAAC vs LAAO by transoesophageal echocardiogram.
around 1 year post procedure

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。

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 (预期的)

2022年10月1日

初级完成 (预期的)

2026年12月31日

研究完成 (预期的)

2026年12月31日

研究注册日期

首次提交

2022年6月12日

首先提交符合 QC 标准的

2022年6月12日

首次发布 (实际的)

2022年6月15日

研究记录更新

最后更新发布 (实际的)

2022年9月21日

上次提交的符合 QC 标准的更新

2022年9月19日

最后验证

2022年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2022.164

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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