4/27-28/2009: National Registry on Safety & Atrial Fibrillation Ablation: An Incubator Think Tank

FDA White Oak Campus Conference Center

10903 New Hampshire Avenue, Silver Spring, MD 20993

April 27-28, 2009

Presentations, agenda, and other material pertinent to the recently concluded 2009 Atrial Fibrillation Ablation Think Tank are provided below.

(All files are in Adobe Acrobat PDF format. Download the free Acrobat Reader program by clicking here.)

Day 1 – Monday, April 27, 2009

07:00-07:30 Registration & Continental Buffet

07:45-09:45 Opening Session

Introduction of Attendees & Brief Welcomes:

Plenary Presentations

National Registries & Federal Paradigms and Lessons Learned:

NCDR Atrial Fibrillation Ablation Registry Data Elements: Preliminary Draft: Stephen Hammill

09:45-11:00 Technical Features of Atrial Fibrillation Ablation: Is Anything Standard, and What Procedural Features Must a Registry Capture?

11:00-11:15 Break

11:15-12:30 Short and Long-Term Safety & Efficacy Outcomes for Afib Ablation: Reaching Consensus On Definition(s) & Data Capture

12:30-13:45 Working Lunch: Quality Control & Post-Market Data Collection

13:45-15:15 Adjunctive Therapy (Anti-Platelet, Anti-Coagulant, Anti-Arrhythmic) & Post-Procedural Monitoring (Clinical, Rhythm, Laboratory): Tools, Duration, Documentation

Adjunctive Rx


15:15-15:30 Break

15:30-17:00 New Paradigms of Collaborative Infrastructure: Impact of the “Fabric” Supporting Safety Registry Efforts

17:00-17:30 Summarizing Day 1

Day 2 – Tuesday, April 28, 2009

07:30-08:00 Continental Breakfast

08:00-09:30 Prospective Registry Objectives & Publications/Information Dissemination: Governance Processes & Statistical Considerations


Processes & Publications

09:30-11:00 Putting It All Together: Priorities & Objectives For An Atrial Fibrillation Ablation Safety Registry

11:00-12:15 Wrap Up: Where Do We Go From Here – Next Steps & Milestones

  • Industry View: Burke Barrett
  • FDA View: Bram Zuckerman
  • Academic/Professional Society View: Peter Kowey
  • NIH View: Alice Mascette
  • Insurance Industry View: Mark Grant
  • CMS View: Marcel Salive
  • Lead Discussant: Richard Page
  • Discussion