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  • Saturday, Mar 9th
    1:00 PM – 7:00 PM ET
    Thinktank on Registry-Facilitated Prospective CV Device Trials: Finding “Goldilocks” Use Cases [Non-CME]
    Location: Monroe
    Symposium
  • Saturday, Mar 9th
    1:00 PM – 1:05 PM ET
    Welcome and Introduction
    Location: Monroe
    Speaker: Bram Zuckerman, MD – U.S. Food and Drug Administration
    Symposium
  • Saturday, Mar 9th
    1:05 PM – 1:15 PM ET
    Global Regulatory Acceptance Working Group
    Location: Monroe
    Speaker: Melanie Raska
    Symposium
  • Saturday, Mar 9th
    1:05 PM – 2:05 PM ET
    SESSION I: SELECTED WORKING GROUP UPDATES & FOCUS 2024
    Location: Monroe
    Moderator: C. Michael Gibson, MD – Beth Israel Deaconess Medical Center
    Moderator: Rebecca Torguson, MPH – FDA
    Symposium
  • Saturday, Mar 9th
    1:15 PM – 1:25 PM ET
    Operations Working Group
    Location: Monroe
    Speaker: Ernest Spitzer, MD – Cardialysis B.V.
    Symposium
  • Saturday, Mar 9th
    1:25 PM – 1:35 PM ET
    Mechanical Circulatory Support Working Group
    Location: Monroe
    Speaker: Andrew D. Althouse, PhD – Medtronic
    Speaker: Eric Vang, PhD, MPH – Medtronic, Inc
    Symposium
  • Saturday, Mar 9th
    1:35 PM – 1:45 PM ET
    Focus 2024: The “Goldilocks” Use Case Construct
    Location: Monroe
    Speaker: Dominic Allocco, MD, MS – Boston Scientific
    Symposium
  • Saturday, Mar 9th
    1:45 PM – 2:05 PM ET
    Discussion Panel
    Location: Monroe
    Panel Moderator: C. Michael Gibson, MD – Beth Israel Deaconess Medical Center
    Panel Moderator: Rebecca Torguson, MPH – FDA
    Panel Discussant: David Erlinge, MD, PhD – Lund University
    Panel Discussant: Ian C. Gilchrist, Sr., MD, MSCAI – Penn State University/Hershey Medical Center
    Panel Discussant: Nicole Gillette – FDA
    Panel Discussant: Graeme Hickey
    Panel Discussant: Charles A. Simonton, MD, FACC, FSCAI – Abiomed Inc
    Panel Discussant: James E. Tcheng, MD – Duke University Health System
    Symposium
  • Saturday, Mar 9th
    2:05 PM – 2:15 PM ET
    Overview of FDA Draft Guidance on DEI
    Location: Monroe
    Symposium
  • Saturday, Mar 9th
    2:05 PM – 3:05 PM ET
    SESSION II: DIVERSITY EQUITY & INCLUSION (DEI) IN CV DEVICE RESEARCH
    Location: Monroe
    Moderator: Dominic Allocco, MD, MS – Boston Scientific
    Moderator: Jennifer Rymer, MD – Duke
    Symposium
  • Saturday, Mar 9th
    2:15 PM – 2:25 PM ET
    “DEI 101”: Fundamental Constructs for Prospective Trials
    Location: Monroe
    Speaker: Michael R. Jaff, DO – Boston Scientific Corporation
    Symposium
  • Saturday, Mar 9th
    2:25 PM – 2:35 PM ET
    DEI Metrics for CV device research -- How do we Measure “Success”?
    Location: Monroe
    Speaker: Wayne Batchelor, MD, MHS – Inova Heart & Vascular Institute
    Symposium
  • Saturday, Mar 9th
    2:35 PM – 2:45 PM ET
    Potential Role of Registries for DEI in Prospective Trials
    Location: Monroe
    Symposium
  • Saturday, Mar 9th
    2:45 PM – 3:05 PM ET
    Discussion Panel
    Location: Monroe
    Panel Moderator: Dominic Allocco, MD, MS – Boston Scientific
    Panel Moderator: Jennifer Rymer, MD – Duke
    Panel Discussant: Roberta Chapman
    Panel Discussant: Megan Coylewright, MD, MPH – The Erlanger Heart and Lung Institute
    Panel Discussant: Alexander C. Fanaroff, MD, MHS – University of Pennsylvania
    Panel Discussant: Michael R. Jaff, DO – Boston Scientific Corporation
    Panel Discussant: Dan Stephens
    Panel Discussant: Michelle Tarver
    Symposium
  • Saturday, Mar 9th
    3:05 PM – 3:15 PM ET
    Update on PTX in PAD Late Safety Signal
    Location: Monroe
    Speaker: Misti Malone, PhD – FDA
    Symposium
  • Saturday, Mar 9th
    3:05 PM – 3:45 PM ET
    Part I: Preventing Disruptive Safety Signals with Predictable, Accessible Long-Term Vital Status
    Location: Monroe
    Symposium
  • Saturday, Mar 9th
    3:05 PM – 4:30 PM ET
    SESSION III: CHALLENGES AND PATHS FORWARD FOR LONG-TERM AND POST-MARKET FOLLOW UP: DEVICE PATIENTS
    Location: Monroe
    Moderator: Kenneth J. Cavanaugh, Jr., PhD – U.S. Food and Drug Administration
    Moderator: Changfu Wu, PhD – Food and Drug Administration
    Symposium
  • Saturday, Mar 9th
    3:15 PM – 3:25 PM ET
    10 Year TAVR Follow Up--An Industry Experience
    Location: Monroe
    Symposium
  • Saturday, Mar 9th
    3:25 PM – 3:35 PM ET
    Sources of Late Safety Signal Bias-Statistical Perspective
    Location: Monroe
    Speaker: Roseann M. White, MA – Edwards Lifesciences
    Symposium
  • Saturday, Mar 9th
    3:35 PM – 3:45 PM ET
    10 Year “Vital Status” Definition and Ascertainment Avenues
    Location: Monroe
    Speaker: Robert W. Yeh, MD, MSc – Beth Israel Deaconess Medical Center
    Symposium
  • Saturday, Mar 9th
    3:45 PM – 3:55 PM ET
    Lessons Learned and Paths Forward with KCCQ Ascertainment: Academic Perspective
    Location: Monroe
    Speaker: David J. Cohen, MD, FSCAI – Cardiovascular Research Foundation
    Symposium
  • Saturday, Mar 9th
    3:45 PM – 4:30 PM ET
    Part II: Long-term and post-market KCCQ Ascertainment: Vital need for Quality of Life Data in Tricuspid Intervention Patients
    Location: Monroe
    Symposium
  • Saturday, Mar 9th
    3:55 PM – 4:05 PM ET
    Lessons Learned and Paths Forward with KCCQ Ascertainment: Trialist Perspective
    Location: Monroe
    Speaker: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
    Symposium
  • Saturday, Mar 9th
    4:05 PM – 4:30 PM ET
    Discussion Panel
    Location: Monroe
    Panel Moderator: Kenneth J. Cavanaugh, Jr., PhD – U.S. Food and Drug Administration
    Panel Moderator: Changfu Wu, PhD – Food and Drug Administration
    Panel Discussant: David Erlinge, MD, PhD – Lund University
    Panel Discussant: Andrew Farb, MD – U.S. Food and Drug Administration
    Panel Discussant: C. Michael Gibson, MD – Beth Israel Deaconess Medical Center
    Panel Discussant: Graeme Hickey
    Panel Discussant: Josh Smale
    Panel Discussant: Ron Waksman, MD, MSCAI – MedStar Washington Hospital Center, MedStar Heart and Vascular Institute
    Symposium
  • Saturday, Mar 9th
    4:30 PM – 4:45 PM ET
    BREAK and TRANSITION TO BREAK-OUT SESSIONS
    Location: Monroe
    Symposium
  • Saturday, Mar 9th
    4:45 PM – 5:55 PM ET
    Diversity, Equity & Inclusion in CV Device Evaluation
    Location: Monroe
    Panel Discussant: Wayne Batchelor, MD, MHS – Inova Heart & Vascular Institute
    Panel Discussant: Brittany Caldwell
    Panel Discussant: Megan Coylewright, MD, MPH – The Erlanger Heart and Lung Institute
    Panel Discussant: Michael R. Jaff, DO – Boston Scientific Corporation
    Panel Discussant: Jennifer Rymer, MD – Duke
    Panel Discussant: Dan Stephens
    Symposium
  • Saturday, Mar 9th
    4:45 PM – 5:55 PM ET
    Long, Long Term Follow-up
    Location: Monroe
    Panel Discussant: David J. Cohen, MD, FSCAI – Cardiovascular Research Foundation
    Panel Discussant: Roseann M. White, MA – Edwards Lifesciences
    Panel Discussant: Changfu Wu, PhD – Food and Drug Administration
    Symposium
  • Saturday, Mar 9th
    4:45 PM – 5:55 PM ET
    Mechanical Circulatory Support
    Location: Monroe
    Panel Discussant: Andrew D. Althouse, PhD – Medtronic
    Panel Discussant: Nicole Gillette – FDA
    Panel Discussant: Charles A. Simonton, MD, FACC, FSCAI – Abiomed Inc
    Symposium
  • Saturday, Mar 9th
    4:45 PM – 5:55 PM ET
    Registry-Supported Trial Operations
    Location: Monroe
    Panel Discussant: David Erlinge, MD, PhD – Lund University
    Panel Discussant: Ernest Spitzer, MD – Cardialysis B.V.
    Panel Discussant: James E. Tcheng, MD – Duke University Health System
    Panel Discussant: Rebecca Torguson, MPH – FDA
    Symposium
  • Saturday, Mar 9th
    4:45 PM – 5:55 PM ET
    SESSION IV: SELECTED WORKING GROUP BREAKOUTS
    Location: Monroe
    Symposium
  • Saturday, Mar 9th
    5:55 PM – 6:00 PM ET
    MINI BREAK TO REASSEMBLE
    Location: Monroe
    Symposium
  • Saturday, Mar 9th
    6:00 PM – 6:10 PM ET
    Mechanical Circulatory Support
    Location: Monroe
    Symposium
  • Saturday, Mar 9th
    6:00 PM – 7:00 PM ET
    SESSION V: REPORTS FROM BREAKOUT SESSIONS
    Location: Monroe
    Moderator: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
    Moderator: Bram Zuckerman, MD – U.S. Food and Drug Administration
    Symposium
  • Saturday, Mar 9th
    6:10 PM – 6:20 PM ET
    Registry-supported Trials Operations
    Location: Monroe
    Symposium
  • Saturday, Mar 9th
    6:20 PM – 6:30 PM ET
    Diversity, Equity & Inclusion in CV Device Evaluation
    Location: Monroe
    Symposium
  • Saturday, Mar 9th
    6:30 PM – 6:40 PM ET
    Long, Long-term Follow-up
    Location: Monroe
    Symposium
  • Saturday, Mar 9th
    6:40 PM – 7:00 PM ET
    Overview Discussion, Comments & Next Steps
    Location: Monroe
    Panel Moderator: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
    Panel Moderator: Bram Zuckerman, MD – U.S. Food and Drug Administration
    Panel Discussant: Dominic Allocco, MD, MS – Boston Scientific
    Panel Discussant: Wayne Batchelor, MD, MHS – Inova Heart & Vascular Institute
    Panel Discussant: Andrew Farb, MD – U.S. Food and Drug Administration
    Panel Discussant: C. Michael Gibson, MD – Beth Israel Deaconess Medical Center
    Panel Discussant: Graeme Hickey
    Panel Discussant: Ernest Spitzer, MD – Cardialysis B.V.
    Panel Discussant: Rebecca Torguson, MPH – FDA
    Symposium
  • Saturday, Mar 9th
    7:00 PM ET
    Adjourn
    Location: Monroe
    Symposium