Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies
Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies
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DOI：
10.1093/europace/euw141
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发表时间：
2017-01-01
期刊：
影响因子：
6.1
通讯作者：
Lewalter, Thorsten
中科院分区：
文献类型：
--
作者：
Tzikas, Apostolos;Holmes, David R., Jr.;Lewalter, Thorsten
随着人们对左心耳闭塞术（LAAO）预防房颤（AF）缺血性卒中的研究兴趣的增加，需要更多关于该治疗的安全性和有效性的临床数据。除了评估治疗在特定患者群体中的有效性外，还需要与药物卒中预防、手术方法和其他器械治疗进行比较。本文记录了来自欧洲和北美相关学科的临床专家、欧洲心脏病学专业学会和医疗器械行业代表就临床研究中需要评估的参数和终点的定义达成的共识。建议遵循这些定义，以便在涉及利益相关者和各种临床学科的LAAO临床研究中实现一致的方法，从而促进对可用治疗策略的持续评估。
The increasing interest in left atrial appendage occlusion (LAAO) for ischaemic stroke prevention in atrial fibrillation (AF) fuels the need for more clinical data on the safety and effectiveness of this therapy. Besides an assessment of the effectiveness of the therapy in specific patients groups, comparisons with pharmacological stroke prophylaxis, surgical approaches, and other device-based therapies are warranted. This paper documents the consensus reached among clinical experts in relevant disciplines from Europe and North America, European cardiology professional societies, and representatives from the medical device industry regarding definitions for parameters and endpoints to be assessed in clinical studies. Adherence to these definitions is proposed in order to achieve a consistent approach across clinical studies on LAAO among the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available.