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Tzikas, Apostolos; Holmes, David R.; Gafoor, Sameer; Ruiz, Carlos E.; Blomström-Lundqvist, Carina; Diener, Hans-Christoph; Cappato, Riccardo; Kar, Saibal; Lee, Randal J.; Byrne, Robert A.; Ibrahim, Reda; Lakkireddy, Dhanunjaya; Soliman, Osama I.; Näbauer, Michael; Schneider, Steffen; Brachman, Johannes; Saver, Jeffrey L.; Tiemane, Klaus; Sievert, Horst; Camm, A. John and Lewalter, Thorsten (2016): Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies. In: Eurointervention, Vol. 12, No. 1: pp. 103-111

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Abstract

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 patient 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 defmitions 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.

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