Loading
Life sciences · Journal article
European Heart Journal · July 9, 2026
A consensus or society position rather than new primary data.
This is a consensus statement from the Left Atrial Appendage Academic Research Consortium that proposes standardized definitions for key endpoints (mortality, stroke, bleeding, device performance) and composite safety and effectiveness measures for LAAC trials. The work aims to harmonize endpoint reporting, improve cross-study comparability, and support regulatory decision-making for this increasingly used alternative to anticoagulation in atrial fibrillation.
Multistakeholder consensus initiative. Clinical experts, regulators, and industry stakeholders involved in LAAC research and evaluation; intended for application to patients with atrial fibrillation at high risk of stroke.. Intervention: Standardized endpoint definitions for LAAC trials (mortality, stroke, bleeding, device performance, composite endpoints).. USA, Europe, and Asia.
Standardized definitions proposed for mortality, stroke, bleeding, and device performance endpoints. Composite endpoints for safety and effectiveness were developed. Consortium included academic researchers, cardiologists, neurologists, clinical trialists, and regulators from USA, Europe, and Asia.
Implementation uptake and impact on trial harmonization are not reported. Standardized definitions proposed for mortality, stroke, bleeding, and device performance endpoints.
Clinicians and trialists should adopt these standardized endpoint definitions to enable consistent reporting and comparison of LAAC trial results and to support regulatory submissions. This guidance is intended to improve research quality and facilitate evidence synthesis for this expanding therapeutic domain.
A consensus statement from an international academic consortium defining standardized endpoints for LAAC trials to harmonize research quality and regulatory evaluation.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians and trialists should adopt these standardized endpoint definitions to enable consistent reporting and comparison of LAAC trial results and to support regulatory submissions. This guidance is intended to improve research quality and facilitate evidence synthesis for this expanding therapeutic domain.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.