Safety Evaluation of Atrial Fibrillation Ablation Using a Collaborative Pan-Stakeholder Critical Path Registry Model: A CSRC ‘Incubator’ Thinktank

An Educational Collaboration between the Cardiac Safety Research Consortium (CSRC), the Duke Clinical Research Institute (DCRI), the American College of Cardiology (ACC), the Heart Rhythm Society (HRS), AdvaMed, and the United States FDA.

11:00-11:10 Opening Session

11:10-11:20 Where We Are Today (Benjamin Eloff, PhD)

  • Governance/Review of Business Plan: What’s been happening since April

11:20-11:30 Regulatory Update (Felipe Aguel, PhD)

  • How will FDA review, manage, and use SAFARI?

11:30-11:40 Review of CMS MedCAC Meeting and its Impact on SAFARI (Marcel Salive, MD)

11:40-11:50 CABANA Update and How It Relates to SAFARI (Douglas Packer, MD)

11:50-12:00 Review of the CRF (Data Form) and beta-testing results (Stephen Hammill, MD)

12:00-12:30 Panel Discussion

Moderator: Peter Kowey, MD (HRS/ACC)

Panelists: All Speakers

Thinktank Panel Discussions (60-90 minutes per subject)

Discussants will give 5 minute introductions to their point of view on the topic. Bullets under each topic are examples of points of discussion – other topics may be discussed.

12:30-14:15 Topic 1: Questions to be addressed by SAFARI

  • Scope of Registry
  • Procedural Safety Questions
  • Chronic Safety
  • Effectiveness Questions
  • How Does Registry Effort Fit with CABANA
  • How are Drugs and Devices Used Together to Treat AF

Moderators: Andrea Natale, MD (HRS/ACC), Marcia Yaross, PhD (AdvaMed)

Discussants: Hugh Calkins, MD (HRS/ACC)Lynnett Voshage-Stahl (AdvaMed), Randall Brockman, MD (FDA), Nancy Foster (Hospital)

Panelists: All Speakers and Discussants, plus Danica Marinca-Dabic, MD (FDA), Yves Rosenberg, MD (NIH), Paul Varosy, MD (NCDR/VA Hospital)

Brief Recap: Douglas Packer, MD

14:15-14:30 Break

14:30-16:00 Topic 2: Phasing if Registry Implementation

  • Plan for Initial Plot
  • Development of the Follow-up Phase of the Registry
  • How Much Follow-up is Needed
  • What Are Some Stopping Rules for SAFARI

Moderators: Kenneth Ellenbogen, MD (HRS/ACC), Kristi Mitchell, MPH (ACC/NCDR)

Discussants: Peter Kowey, MD (HRS/ACC)Hay Millerhagen, MS (AdvaMed), Ellen Pinnow, MS (FDA), Nancy Foster (Hospital), Alice Mascette, MD (NHLBI), Elise Berliner, PhD (AHRQ)

Brief Recap: Stephen Hammill, MD

16:00-17:00 Topic 3: Funding Issues/Opportunities for Registry Development

  • What Needs to be Paid For
  • What Public Funding Opportunities Exist
  • What Would Other Investors get out of SAFARI

Moderators: Sana Al-Khatib, MD (HRS/ACC), Mitchell Krucoff, MD (CSRC)

Discussants: Ralph Brindis, MD (ACC), Ruey Dempsey (AdvaMed), Alice Mascette, MD (NHLBI)

Panelists: Sana Al-Khatib, MD, Paul Varosy, MD, Jeremy Ruskin, MD, Benjamin Eloff, PhD, Ralph Brindis, MD, Ruey DEmpsey, Alice Mascetter, MD, Elise Berliner, PhD, Mitchell Krucoff, MD

Brief Recap: Jeremy Ruskin, MD

17:00-18:00 Topic 4: SAFARI and the Future

  • How Should SAFARI Adapt to New Therapies
  • How Does SAFARI Fit with OTher AF Registry Efforts
  • Moving From Drug or Device to Drug and Device Therapy for AF

Moderators: Albert Waldo, MD (Academics), Benjamin Eloff, PhD (FDA)

Discussants: Hugh Calkins, MDMarcia Yaross, PhDThomas Gross, MD

Panelists: David Wilber, MD, Richard Shemin, MD, Hugh Calkins, MD, Marcia Yaross, PhD, Albert Waldo, MD, Thomas Gross, MD, Marcel Salive, MD, Mitchell Krucoff, MD, Benjamin Eloff, PhD

Brief Recap: David Wilber, MD

18:00-18:15 Wrap-up and Adjournment

  • SAFARI Executive Operations Committee (Peter Kowey, MD)
  • CSRC (Mitchell Krucoff, MD)