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.
authors.affiliation: AHEPA University Hospital, Thessaloniki, Greece.
authors.forename: Apostolos
authors.initials: A
authors.lastname: Tzikas
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
authors.forename: Sameer
authors.initials: S
authors.lastname: Gafoor
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Ruiz
authors.forename: Carina
authors.initials: C
authors.lastname: Blomström-Lundqvist
authors.forename: Hans-Christoph
authors.initials: HC
authors.lastname: Diener
authors.forename: Riccardo
authors.initials: R
authors.lastname: Cappato
authors.forename: Saibal
authors.initials: S
authors.lastname: Kar
authors.forename: Randal J
authors.initials: RJ
authors.lastname: Lee
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.forename: Reda
authors.initials: R
authors.lastname: Ibrahim
authors.forename: Dhanunjaya
authors.initials: D
authors.lastname: Lakkireddy
authors.forename: Osama I
authors.initials: OI
authors.lastname: Soliman
authors.forename: Michael
authors.initials: M
authors.lastname: Näbauer
authors.forename: Steffen
authors.initials: S
authors.lastname: Schneider
authors.forename: Johannes
authors.initials: J
authors.lastname: Brachman
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Saver
authors.forename: Klaus
authors.initials: K
authors.lastname: Tiemann
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.forename: A John
authors.initials: AJ
authors.lastname: Camm
authors.forename: Thorsten
authors.initials: T
authors.lastname: Lewalter
mesh_terms: D000925:Anticoagulants / Q000627:therapeutic use*; D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000628:therapy*; D003625:Data Collection; D006801:Humans; D020521:Stroke / Q000517:prevention & control / Q000628:therapy*
chemical_list: D000925:Anticoagulants