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Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data
Apostolos Tzikas1, David R Holmes2, Sameer Gafoor3
1Department of Cardiology, AHEPA University Hospital, Asklipiou 10, 57001 Thessaloniki, Greece th.lewalter@uni-bonn.de aptzikas@yahoo.com.
Insights
Left atrial appendage occlusion (LAAO) is a stroke prevention therapy for atrial fibrillation (AF). Experts propose standardized definitions for LAAO clinical studies to ensure consistent data collection and evaluation.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Research
Background:
- Growing interest in Left Atrial Appendage Occlusion (LAAO) for preventing ischemic stroke in atrial fibrillation (AF) necessitates robust clinical data.
- Existing data requires expansion regarding LAAO's safety and effectiveness across diverse patient groups.
- Comparisons between LAAO, pharmacological prophylaxis, surgical interventions, and other device-based therapies are crucial.
Framework:
- A consensus was reached by European and North American clinical experts, cardiology societies, and industry representatives.
- Standardized definitions for parameters and endpoints in LAAO clinical studies were established.
- This framework aims to unify data assessment across multiple stakeholders and disciplines.
Implementation:
- The proposed definitions are intended for adoption in ongoing and future clinical studies on LAAO.
- Consistent application of these definitions will facilitate direct comparisons between different studies and approaches.
- This standardization supports the rigorous evaluation of LAAO as a therapeutic strategy.
Implications:
- Adherence to standardized definitions will enhance the comparability and reliability of clinical trial outcomes.
- Facilitates a clearer understanding of LAAO's role in stroke prevention for atrial fibrillation patients.
- Supports evidence-based decision-making for clinicians, researchers, and the medical device industry.
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 patients 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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