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INTERVENTIONS FOR HYPERTENSION AND STROKE

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

1. AHEPA University Hospital, Thessaloniki, Greece; 2. Mayo Clinic, Rochester, MN, USA; 3. CardioVascular Center Frankfurt, Frankfurt, Germany; 4. Hackensack UMC Heart and Vascular Hospital and The Joseph M. Sanzari Children’s Hospital, Hackensack, NJ, USA; 5. Department of Cardiology, Institution of Medical Science, Uppsala University, Uppsala, Sweden; 6. Department of Neurology, University Hospital Essen, University Duisburg-Essen, Essen, Germany; 7. Arrhythmia and Electrophysiology Research Center, IRCCS Humanitas Research Hospital, Milan, Italy, and Arrhythmia and Electrophysiology II Center, Humanitas Gavazzeni Clinics, Bergamo, Italy; 8. Cedars-Sinai Medical Center, Los Angeles, CA, USA; 9. Cardiovascular Research Institute and Department of Medicine, University of California San Francisco, San Francisco, CA, USA; 10. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; 11. Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada; 12. Bloch Heart Rhythm Center, KU Cardiovascular Research Institute, University of Kansas Hospital, Kansas City, KS, USA; 13. Cardialysis and Department of Cardiology, Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands; 14. Medizinische Klinik und Poliklinik I, Ludwig-Maximilians-Universität, Munich, Germany; 15. Stiftung Institut für Herzinfarktforschung (Foundation IHF), Ludwigshafen, Germany; 16. II. Med. Hospital Klinikum Coburg GmbH, Coburg, Germany; 17. Comprehensive Stroke Center and Department of Neurology, David Geffen School of Medicine at the University of California, Los Angeles, CA, USA; 18. Department of Nuclear Medicine, Technical University of Munich, Munich, Germany; 19. Cardiovascular and Cell Sciences Research Institute, St. George’s, University of London, London, United Kingdom; 20. Department of Medicine-Cardiology and Intensive Care, Peter Osypka Heart Center, Clinic Munich-Thalkirchen, Munich, Germany

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.

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