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

  • 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 Näbauer
  • , Steffen Schneider
  • , Johannes Brachman
  • , Jeffrey L. Saver
  • , Klaus Tiemann
  • , Horst Sievert
  • , A. John Camm
  • Thorsten Lewalter
  • AHEPA University Hospital
  • Mayo Clinic
  • CardioVascular Center Frankfurt
  • Joseph M. Sanzari Children's Hospital
  • Uppsala University
  • University Clinics
  • Humanitas Research Hospital
  • Humanitas Gavazzeni Clinics
  • Cedars-Sinai Medical Center
  • University of California San Francisco
  • Technical University Munich
  • Université de Montréal
  • University of Kansas Health System
  • Cardialysis BV
  • Ludwig-Maximilians-University
  • Foundation IHF
  • II. Med. Hospital Klinikum Coburg GmbH
  • McGill University
  • St. Georges Hospital
  • Clinic Munich-Thalkirchen

Research output: Contribution to a Journal (Peer & Non Peer)Articlepeer-review

95 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)103-111
Number of pages9
JournalEuroIntervention
Volume12
Issue number1
DOIs
Publication statusPublished - May 2016
Externally publishedYes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

  1. SDG 3 - Good Health and Well-being
    SDG 3 Good Health and Well-being

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