Predicted outcomes and real-life impact
AF-B-STEP will generate a comprehensive, data-driven understanding of Atrial Fibrillation (AF) burden, clarifying its progression, clinical consequences, and impact on quality of life. By standardising AF burden measurement and linking it to major health outcomes, the project will enable evidence-based, precision-guided treatment decisions and support regulatory acceptance of AF burden as a meaningful endpoint. Ultimately, this approach aims to improve cardiovascular outcomes, reduce healthcare costs, and accelerate innovation in AF care. Below, we summarise more specific areas of impact.
Robust description of AF burden distributions and trajectories
The project will generate a comprehensive and data-driven understanding of how atrial fibrillation (AF) burden develops across populations and patient groups. This includes temporal patterns, progression, and differences by sex and clinical characteristics. Such knowledge is currently fragmented and will be unified through large-scale integrated datasets.
Quantification of the effect of AF burden on major health outcomes
AF-B-STEP will establish how AF burden contributes to stroke, heart failure, cardiovascular death, and other clinical endpoints. By linking AF burden data with longitudinal health outcomes, the project will move beyond correlation toward clinically meaningful risk quantification. This enables better prediction and prevention strategies.
Understanding of AF burden impact on patient-reported outcomes and quality of life
The project will clarify how AF burden influences symptoms, cognitive function, and quality of life. This fills a major gap, as current evidence on patient-centred outcomes is limited and inconsistent. The results will support more holistic, patient-centred care approaches.
Standardised AF burden reporting across devices and platforms
A key outcome is the development of unified standards for measuring and reporting AF burden across implantable devices, wearables, and diagnostics. This will resolve current inconsistencies that limit comparability and clinical usability. Standardisation is essential for both research and regulatory acceptance.
Validated role of AF burden in clinical decision-making and therapy
The project will define how AF burden can guide treatment decisions, including thresholds for intervention. This will enable precision medicine approaches, replacing current uncertainty about who benefits from therapy. It also supports integration into clinical guidelines.
Improved cardiovascular outcomes and reduced disease burden
By enabling better diagnosis and targeted therapy, AF-B-STEP aims to reduce AF-related morbidity and mortality by up to ~25%. This reflects the long-term clinical impact of applying AF burden-based strategies.
Reduction in healthcare costs and improved cost-effectiveness
The project is expected to reduce AF-related healthcare costs by up to ~20% through better targeting of therapies and avoidance of unnecessary treatments. Economic analyses will support adoption by healthcare systems and payers.
Acceleration of innovation and regulatory acceptance
By generating high-quality evidence, AF-B-STEP will support regulators (e.g., EMA/FDA) in accepting AF burden as a meaningful endpoint. This can accelerate development and approval of new therapies and technologies.
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