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Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies.

Tzikas, A; Holmes, DR; Gafoor, S; Ruiz, CE; Blomström-Lundqvist, C; Diener, H-C; Cappato, R; Kar, S; Lee, RJ; Byrne, RA; et al. Tzikas, A; Holmes, DR; Gafoor, S; Ruiz, CE; Blomström-Lundqvist, C; Diener, H-C; Cappato, R; Kar, S; Lee, RJ; Byrne, RA; Ibrahim, R; Lakkireddy, D; Soliman, OI; Nabauer, M; Schneider, S; Brachmann, J; Saver, JL; Tiemann, K; Sievert, H; Camm, AJ; Lewalter, T (2017) Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Europace, 19 (1). pp. 4-15. ISSN 1532-2092 https://doi.org/10.1093/europace/euw141
SGUL Authors: Camm, Alan John

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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 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.

Item Type: Article
Additional Information: This is a pre-copyedited, author-produced version of an article accepted for publication in EP Europace following peer review. The version of record Apostolos Tzikas, David R. Holmes, Sameer Gafoor, Carlos E. Ruiz, Carina Blomström-Lundqvist, Hans-Christoph Diener, Riccardo Cappato, Saibal Kar, Randal J. Lee, Robert A. Byrne, Reda Ibrahim, Dhanunjaya Lakkireddy, Osama I. Soliman, Michael Nabauer, Steffen Schneider, Johannes Brachmann, Jeffrey L. Saver, Klaus Tiemann, Horst Sievert, A. John Camm, Thorsten Lewalter; Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies, EP Europace, Volume 19, Issue 1, 1 January 2017, Pages 4–15 is available online at: https://doi.org/10.1093/europace/euw141
Keywords: Atrial Fibrillation, LAA closure, Prevention, Stroke, Atrial Appendage, Atrial Fibrillation, Brain Ischemia, Cardiac Catheterization, Consensus, Cooperative Behavior, Data Collection, Endpoint Determination, Humans, Interdisciplinary Communication, International Cooperation, Patient Selection, Research Design, Risk Factors, Stroke, Treatment Outcome, Atrial Fibrillation, Stroke, Prevention, LAA closure, Cardiovascular System & Hematology, 1103 Clinical Sciences
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Academic Structure > Molecular and Clinical Sciences Research Institute (MCS) > Cardiac (INCCCA)
Journal or Publication Title: Europace
ISSN: 1532-2092
Language: eng
Dates:
DateEvent
January 2017Published
16 August 2016Published Online
Publisher License: Publisher's own licence
PubMed ID: 27540038
Web of Science ID: WOS:000397055100002
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/109372
Publisher's version: https://doi.org/10.1093/europace/euw141

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