regulatory science innovation forum series

Date: April 16, 2025   |   Location: Washington, D.C.   |   Time: 8am to 4pm (ET)

Using Atrial Fibrillation Burden as a Regulatory Outcome

Contribute your thoughts along with the FDA, industry, and academic experts in a focused discussion to help define the best current thinking on the use of atrial fibrillation burden as a regulatory endpoint.

Specific topics to be discussed are:

  • Can AFib burden be used in its current form to achieve clinical and regulatory goals?
  • Can AFib burden serve as a surrogate for heart failure, stroke, hospitalization, quality of life, or cognitive decline?
  • Should AFib burden be measured continuously or intermittently?
  • Does the measurement of AFib burden require a new statistical approach?

Findings will be published in a multi-stakeholder-authored peer-reviewed manuscript.

To be part of this important discussion, please join us on April 16th, 2025, in Washington, DC. Spaces are limited, so register as soon as possible. 

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