@article{3d95b72cec5c43a0bff5fcd01b0102a7,
title = "Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies",
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 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.",
author = "Apostolos Tzikas and Holmes, {David R.} and Sameer Gafoor and Ruiz, {Carlos E.} and Carina Blomstr{\"o}m-Lundqvist and Diener, {Hans Christoph} and Riccardo Cappato and Saibal Kar and {J. Lee}, Randal and Byrne, {Robert A.} and Reda Ibrahim and Dhanunjaya Lakkireddy and Soliman, {Osama I.} and Michael N{\"a}bauer and Steffen Schneider and Johannes Brachman and Saver, {Jeffrey L.} and Klaus Tiemann and Horst Sievert and Camm, {A. John} and Thorsten Lewalter",
note = "Funding Information: A. Tzikas: consultant, research grant, St. Jude Medical. D.R. Holmes: Mayo Clinic and D. Holmes have licensed technology for LAAO to Boston Scientific. C.E. Ruiz: consultant, research grant, Philips and St. Jude Medical. C. Blomstr?m-Lundqvist: consultant, research grant, Medtronic, Cardiome, Boston Scientific. H-C. Diener: received honoraria for participation in clinical trials, contribution to advisory boards or oral presentations from Abbott, Allergan, AstraZeneca, Bayer Vital, BMS, Boehringer Ingelheim, CoAxia, Corimmun, Covidien, Daiichi Sankyo, D-Pharm, Fresenius, GlaxoSmithKline, Janssen-Cilag, Johnson & Johnson, Knoll, Lilly, MSD, Medtronic, MindFrame, Neurobiological Technologies, Novartis, Novo Nordisk, Paion, Parke-Davis, Pfizer, Sanofi-Aventis, Schering-Plough, Servier, Solvay, St. Jude, Syngis, Talecris, Thrombogenics, WebMD Global, Wyeth and Yamanouchi. Financial support for research projects was provided by AstraZeneca, GSK, Boehringer Ingelheim, Lundbeck, Novartis, Janssen-Cilag, Sanofi-Aventis, Syngis and Talecris. The Department of Neurology at the University Duisburg-Essen received research grants from the German Research Council (DFG), German Ministry of Education and Research (BMBF), European Union, NIH, Bertelsmann Foundation and Heinz-Nixdorf Foundation. H-C. Diener has no ownership interest in and does not own stocks of any pharmaceutical company. R. Cappato: consultant, research grant, Boston Scientific, Biosense Webster, St. Jude Medical, Medtronic. S. Kar: served as an advisor or consultant for Abbott Vascular and Boston Scientific, received grants for clinical research from Abbott Vascular, Boston Scientific and St. Jude Medical, and owns stock, stock options, or bonds from Coherex Medical, Inc. R.J. Lee: consultant and equity holder in SentreHEART, Inc. R.A. Byrne: reports speaker's fees from B. Braun Melsungen, Biotronik and Boston Scientific. R. Ibrahim: consultant and proctor, St. Jude Medical. D. Lakireddy: consultant to SJM/Biosense Webster, advisory board for SentreHEART/AtriCure, speaker for Biotronik/Janssen/Boehringer Ingelheim/Pfizer. M. N?bauer: speaker honoraria, St. Jude Medical. J. Brachman: research funding, speaker's bureau, advisory board, Boston Scientific, St. Jude Medical, Lifetech, Occlutech. Publisher Copyright: {\textcopyright} The Authors 2016.",
year = "2016",
month = may,
doi = "10.4244/EIJV12I1A18",
language = "English (US)",
volume = "12",
pages = "103--111",
journal = "EuroIntervention",
issn = "1774-024X",
publisher = "EuroPCR",
number = "1",
}