Electrophysiology Collaboratory

Overview

The Electrophysiology Collaboratory (EPC) is a collaborative initiative designed to enhance the efficiency and effectiveness of EFS in electrophysiology. With support from the FDA and Stanford’s Center for Arrhythmia Research, the program addresses key challenges facing electrophysiology EFS in the United States, working to streamline processes and advance innovation in the field.

Objective

To reduce barriers to early clinical studies with novel EP technologies in the U.S. by broadening site participation, improving preparedness, and establishing standardized protocols, ultimately accelerating patient access to innovative electrophysiology treatments.

Electrophysiology Collaboratory

The EPC connects emerging EFS organizations with EP clinical champions to support sponsors conducting EFS studies. By enhancing clinical site readiness and standardizing protocols, the group addresses inefficiencies that have previously shifted EP research outside the U.S. These efforts aim to foster a supportive environment for EP innovation and research within the U.S., ultimately accelerating patient access to novel electrophysiology.

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Video Resource

Early Feasibility Studies in the Electrophysiology Space

A recent panel highlighted how EFS helps these developers navigate requirements while advancing innovative EP devices. The discussion emphasized the importance of early and frequent FDA interaction, strategic site selection, and a collaborative approach to improve the efficiency of early-stage clinical trials in the U.S. electrophysiology space.
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Featured Resource

Accelerate EFS Toolkit

MDIC’s work within the EFS program includes tracking EFS performance metrics, and developing tools and best practices for EFS sponsors and clinical researchers alike. In combination, these efforts are anticipated to drive overall EFS efficiency and support continuous assessment of EFS efficiency and effectiveness for US patients.

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Early Feasibility Study Resources

EFS Participant Landscape

MDIC EFS Blueprint

EFS Site Best Practices Workshop