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.
EPC - Academic Research Consortium (ARC) Atrial Fibrillation Ablation Endpoints
Project Summary
This project focuses on advancing the development and standardization of clinical trial endpoints for atrial fibrillation (AF). The initiative addresses critical components of trial design, safety, and efficacy to improve the quality and consistency of evidence generated for regulatory and clinical decision-making.
Early Feasibility Studies in the Electrophysiology Space
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.
