Standardized endpoint definitions for trials of transcatheter left atrial appendage closure: a consensus from the Left Atrial Appendage Academic Research Consortium

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ID: 320278
2026
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Abstract
Abstract Since its introduction in 2002, left atrial appendage closure (LAAC) has rapidly expanded as an alternative to anticoagulation in patients with atrial fibrillation at high risk of stroke. Harmonized processes for data collection, analysis, and reporting in LAAC trials are essential to enhance research quality and improve clinical practice. The Left Atrial Appendage Academic Research Consortium (LAARC) initiative is an independent collaboration of academic research organizations, cardiology and neurology experts, clinical trialists, and regulatory authorities from the USA, Europe, and Asia. The consortium engaged clinical experts, regulators—including the US Food and Drug Administration (FDA), European Notified Bodies, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)—and industry leaders to define standardized study elements and endpoints for LAAC trials. Key considerations included alignment with prior Academic Research Consortium initiatives, procedural and mechanistic insights, and clinical relevance. Consensus definitions were proposed for mortality, stroke, bleeding, and device performance, along with composite endpoints for safety and effectiveness. The proposed LAARC consensus definitions aim to standardize endpoint reporting, improve comparability across studies, and support regulatory and clinical trial applications for this evolving therapy through broad dissemination in the peer-reviewed literature.
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Authors Philippe Garot, Roxana Mehran, Ole De Backer, James V. Freeman, Nina Wunderlich, Benjamin Hibbert, Apostolos Tzikas, Devi Nair, Sergio Berti, Jacqueline Saw, Xavier Freixa, Shephal K. Doshi, I Cruz-Gonzalez, Megan Coylewright, Adel Aminian, Matthew J. Price, Lorenz Räber, Xiaoxi Yao, L Sanchis, Christian T Ruff, Ulf Landmesser, Dhanunjaya Lakkireddy, Christopher R. Ellis, Mirvat Alasnag, Masanori Yamamoto, Enrico G. Ferro, Shin Iwamoto, Takeshi Shiba, Y Z Jin, Boris Schmidt, Vikrant Jagadeesan, Vivek Y. Reddy, David Hildick‐Smith, Angelo Oliva, Mitchell W. Krucoff, Ernest Spitzer, Jens Erik Nielsen-Kudsk, C Michael Gibson, Edip Mahmut Gurol, Don E Cutlip, Martin B Leon, David R. Holmes, M C Morice, Mohamad Alkhouli
Journal european heart journal
Year 2026
DOI
10.1093/eurheartj/ehag482
URL
https://doi.org/10.1093/eurheartj/ehag482
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