Considerations for using atrial fibrillation burden as a surrogate endpoint: A report from the Cardiovascular...

Area of Science:

• Cardiovascular Medicine
• Clinical Trials Methodology
• Biomedical Engineering

Background:

• Current atrial fibrillation (AF) management prioritizes early rhythm control to mitigate AF-related risks and enhance patient quality of life.
• Existing AF clinical trials utilize outdated treatment failure definitions, such as minimal AF recurrence or infrequent traditional endpoints (stroke, heart failure, death), which are inadequate for contemporary patient populations.
• There is a need for a direct, clinically meaningful measure to assess treatment efficacy in AF trials, potentially accelerating research and reducing costs.

Purpose of the Study:

• To propose and establish atrial fibrillation (AF) burden as a validated surrogate clinical endpoint for AF rhythm control trials.
• To outline a roadmap for the collaborative validation of AF burden as a surrogate endpoint.
• To provide standards for measuring AF burden across various devices and modalities.

Main Methods:

• A Think Tank convened experts from science, clinical practice, regulatory bodies, and industry to develop a strategy for AF burden validation.
• Review of existing data supporting AF burden as a surrogate endpoint.
• Development of measurement standards and a collaborative validation roadmap.

Main Results:

• The document reviews current evidence supporting AF burden as a surrogate endpoint.
• Standards for AF burden measurement using contemporary devices are proposed.
• A practical roadmap for collaborative validation of AF burden is established.

Conclusions:

• Atrial fibrillation (AF) burden offers a patient-centric approach, moving beyond historical treatment success metrics.
• Leveraging modern monitoring technology, AF burden can serve as an early indicator of AF-related risk.
• Validating AF burden as a surrogate endpoint can significantly enhance the efficiency and relevance of AF clinical trials.