The EP Collaboratory: A New Initiative Focused on Early Feasibility Studies and Consensus AF Ablation Endpoint Definitions for Clinical Trials-The EP Collaboratory: A New Initiative Focused on Early Feasibility Studies and Consensus AF Ablation Endpoint Definitions for Clinical Trials

The EP Collaboratory: A New Initiative Focused on Early Feasibility Studies and Consensus AF Ablation Endpoint Definitions for Clinical Trials

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Video Summary

The session discussed the concept and importance of collaborative communities, especially in the medical field, focusing on the Electrophysiology (EP) Collaboratory. Emily Zeitler and Paul Wong from Stanford moderated the session at Heart Rhythm 2025. The EP Collaboratory is a forum for private and public sector members to address medical device challenges collaboratively. Such communities, including the FDA, aim to develop and streamline processes, enhance regulatory science, and improve outcomes for medical devices, mirroring successful examples like the Heart Valve and Heart Failure Collaboratories.<br /><br />One central theme was the importance of early feasibility studies (EFS) within the U.S. This approach allows for iterative evaluation of medical devices in early-stage development, with the goal of aligning clinical safety and efficacy assessments before progressing to larger trials. It emphasizes the significance of early U.S. user experience data, crucial for FDA approvals.<br /><br />Presentations also highlighted specific initiatives like the Academic Research Consortium (AHRQ) for advancing atrial fibrillation (AF) endpoint standards and the ongoing dialogues between various stakeholders, including the FDA, Heart Rhythm Society (HRS), and MDIC.<br /><br />Ken Vilcek from HRS underscored the society's supportive role, while mentioning complementary efforts like the HRS Research Network aimed at broader clinical and scientific challenges. Throughout, the panel stressed the need for engagement from startups and small businesses to foster innovation and benefit the larger ecosystem. The session concluded with a call for active participation and collaboration in these community-driven initiatives.

Keywords

collaborative communities

Electrophysiology Collaboratory

medical devices

early feasibility studies

FDA

Heart Rhythm 2025

atrial fibrillation

Heart Rhythm Society

clinical trials

innovation