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

Apostolos Tzikas, David 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 CammThorsten Lewalter

Research output: Contribution to journalArticle

31 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 (US)
Pages (from-to)103-111
Number of pages9
JournalEuroIntervention
Volume12
Issue number1
DOIs
StatePublished - May 1 2016

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Atrial Appendage
Stroke
Equipment and Supplies
Therapeutics
North America
Cardiology
Atrial Fibrillation
Industry
Pharmacology
Safety
Clinical Studies

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Percutaneous left atrial appendage occlusion : the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies. / Tzikas, Apostolos; Holmes, David; Gafoor, Sameer; Ruiz, Carlos E.; Blomström-Lundqvist, Carina; Diener, Hans Christoph; Cappato, Riccardo; Kar, Saibal; J. Lee, Randal; Byrne, Robert A.; Ibrahim, Reda; Lakkireddy, Dhanunjaya; Soliman, Osama I.; Näbauer, Michael; Schneider, Steffen; Brachman, Johannes; Saver, Jeffrey L.; Tiemann, Klaus; Sievert, Horst; Camm, A. John; Lewalter, Thorsten.

In: EuroIntervention, Vol. 12, No. 1, 01.05.2016, p. 103-111.

Research output: Contribution to journalArticle

Tzikas, A, Holmes, D, Gafoor, S, Ruiz, CE, Blomström-Lundqvist, C, Diener, HC, Cappato, R, Kar, S, J. Lee, R, Byrne, RA, Ibrahim, R, Lakkireddy, D, Soliman, OI, Näbauer, M, Schneider, S, Brachman, J, Saver, JL, Tiemann, K, Sievert, H, Camm, AJ & Lewalter, T 2016, 'Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies', EuroIntervention, vol. 12, no. 1, pp. 103-111. https://doi.org/10.4244/EIJV12I1A18
Tzikas, Apostolos ; Holmes, David ; Gafoor, Sameer ; Ruiz, Carlos E. ; Blomström-Lundqvist, Carina ; Diener, Hans Christoph ; Cappato, Riccardo ; Kar, Saibal ; J. Lee, Randal ; Byrne, Robert A. ; Ibrahim, Reda ; Lakkireddy, Dhanunjaya ; Soliman, Osama I. ; Näbauer, Michael ; Schneider, Steffen ; Brachman, Johannes ; Saver, Jeffrey L. ; Tiemann, Klaus ; Sievert, Horst ; Camm, A. John ; Lewalter, Thorsten. / Percutaneous left atrial appendage occlusion : the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies. In: EuroIntervention. 2016 ; Vol. 12, No. 1. pp. 103-111.
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