The proposed session follows from the 2023 HRS Featured Symposium (HP-438228) “Roundtable/FDA: The ABCs of EFS: Discussion of Early Feasibility Studies in EP with the FDA, Investigators, and Industry. Presented by the Medical Device Innovations Consortium” and the 2022 HRS Session EN-613 ”Roundtable/FDA: Early Feasibility Studies in the US: Discussion with FDA, Industry and Investigators.”
For 2025, we will describe the creation of a new EP Collaboratory (EPC), which will bring together stakeholders (HRS, clinical investigators, the industry, regulators, clinical site research staff. payors, and patient advocates) to facilitate clinical studies in the EP/arrhythmia space. The Collaboratory will initially focus on two projects: (1) EP EFS best practices and formation of an EP clinical site EFS network and (2) Establishing an Academic Research Consortium (ARC) which will bring together academic leaders, the FDA, and industry to develop consensus AF ablation clinical trial endpoint definitions for clinical studies intended for clinical practice and regulatory review.

• Describe the role of the EP Collaboratory in facilitating and improving EP clinical studies.
• Outline the steps to facilitate Early Feasibility Clinical Trials.
• Explain the role of the Academic Research Consortium to develop consensus AF ablation clinical trial endpoint definitions for clinical studies.

Emily Zeitler, MD, MHS
Paul Wang, MD

Collaborative Communities
Presenter(s): Emily P. Zeitler, MD, MHS

Creating the EP Collaboratory
Presenter(s): J. Peter Weiss, MD, MSci

Facilitating Early Feasibility Studies
Presenter(s): Paul J. Wang, MD

Developing New AF Ablation Endpoints
Presenter(s): T. Jared Bunch, MD

HRS Commentary
Presenter(s): Kenneth C. Bilchick, MD, MS

Emily Zeitler:

• Boston Scientific (Honoraria/Speaking/Consulting Fee - Speaking and Teaching)
• Boston Scientific (Honoraria/Speaking/Consulting Fee - Research)
• Abbott (Honoraria/Speaking/Consulting Fee - Speaking and Teaching)
• Biosense Webster, Inc. (Honoraria/Speaking/Consulting Fee - Consulting)
• Medtronic (Honoraria/Speaking/Consulting Fee - Membership on Advisory Committees or Review Panels)
• Element Science, Inc (Honoraria/Speaking/Consulting Fee - Consulting)

J. Peter Weiss:

• Abbott Medical (Honoraria/Speaking/Consulting Fee - Speaking and Teaching)
• Biotronik (Honoraria/Speaking/Consulting Fee - Speaking and Teaching)
• Stereotaxis, Inc. (Honoraria/Speaking/Consulting Fee - Consulting)
• Galaxy Medical, Inc (Honoraria/Speaking/Consulting Fee - Consulting)
• Acutus Medical Inc (Honoraria/Speaking/Consulting Fee - Consulting)
• Circa Scientific (Honoraria/Speaking/Consulting Fee - Consulting)
• Corfigo (Honoraria/Speaking/Consulting Fee - Consulting)
• Talon Surgical Inc. (Stock Options – Privately Held (including start-up companies) - Consulting)

Paul Wang:

• EpiEndoAF (Honoraria/Speaking/Consulting Fee - Consulting)
• HrtEx, Inc. (Ownership/Partnership/Principal - Ownership)
• Soneira (Stock Options – Privately Held (including start-up companies) - Consulting)

T. Jared Bunch:

• Boehringer Ingelheim (Research (Contracted Grants for PIs and Named Investigators only) - Research)
• Altathera (Research (Contracted Grants for PIs and Named Investigators only) - Research)
• Biosense Webster, Inc. (Training for new ablation balloon - Required training for new ablation balloon to start institutional research on the device)
• Pfizer, Inc. (Honoraria/Speaking/Consulting Fee - HRS committee for AF management - BMS/Pfizer Alliance and HRS Roundtable)
• Abbott (Research (Contracted Grants for PIs and Named Investigators only) - Research)
• Altathera (Research (Contracted Grants for PIs and Named Investigators only) - Creation of an education video based upon PEAKS registry data/study)

Kenneth Bilchick:

• Nothing Relevant to Disclose

To view all Heart Rhythm 2025 Faculty Disclosures, please click here.