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:
- CSRC/DCRI: Mitchell Krucoff
- FDA: Daniel Schultz
- ACC: Janet Wright
- HRS: Stephen Hammill
- Industry: Ruey Dempsey
- Anatomy of a Cardiac Safety Think Tank: Mitchell Krucoff
Plenary Presentations
- Concept, Challenges, Uptake, & Adoption of Atrial Fibrillation Ablation:
- Academic View: Douglas Packer
- FDA View: Randall Brockman
- Pharma Industry View: David Feigal
- Device Industry View: Marcia Yaross
National Registries & Federal Paradigms and Lessons Learned:
- ACC NCDR Registry Experience: Jeptha Curtis
- FDA Post-Market Endeavors: Danica Marinac-Dabic
- Industry Registry Experience: Dan Schaber
- CMS ICD “Pay for Data” Model: Marcel Salive
- Critical Path Collaborations: Obligatory Drug-Device Safety Interactions: Mitchell Krucoff
- STS Registry Experience: Mitchell Magee
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?
- Academic View: Imaging: Hugh Calkins
- Academic View: Technique: Kenneth Ellenbogen
- Industry View: Imaging and Technique: Jay Millerhagen
- FDA View: Imaging and Technique: Jun Dong
- Lead Discussant: Eric Prystowsky
- Discussion
- Brief Recap: Eric Prystowsky
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
- Industry View: Julie Broderick
- FDA View: Felipe Aguel
- Academic/Professional Society View: Andrea Natale
- CMS View: Marcel Salive
- NIH View: Alice Mascette
- Lead Discussant: Philip Sager
- Discussion
- Brief Recap: Philip Sager
12:30-13:45 Working Lunch: Quality Control & Post-Market Data Collection
- Academic/Professional Society View: Sana Al-Khatib
- FDA View: Ellen Pinnow
- Industry View: Lynette Voshage-Stahl
- Lead Discussant: Mitchell Magee
- Discussion
- Brief Recap: Mitchell Magee
13:45-15:15 Adjunctive Therapy (Anti-Platelet, Anti-Coagulant, Anti-Arrhythmic) & Post-Procedural Monitoring (Clinical, Rhythm, Laboratory): Tools, Duration, Documentation
Adjunctive Rx
- Academic View: James Reiffel
- Industry View: Andrew Koren
- FDA View: Norman Stockbridge
Monitoring
- Academic View: Albert Waldo
- Industry View: Jay Millerhagen
- FDA View: Randall Brockman
- Lead Discussant: Peter Kowey
- Discussion
- Brief Recap: Peter Kowey
15:15-15:30 Break
15:30-17:00 New Paradigms of Collaborative Infrastructure: Impact of the “Fabric” Supporting Safety Registry Efforts
- Academic/Professional Society View: Stephen Hammill
- Industry View: Ruey Dempsey
- FDA View: Wendy Sanhai
- NIH View: Yves Rosenberg
- Lead Discussant: Benjamin Eloff
- Discussion
- Brief Recap: Benjamin Eloff
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
Statistics
Processes & Publications
- Academic View: Richard Page
- Industry View: John Finkle
- FDA View: Benjamin Eloff
- Lead Discussant: Daniel Mark
- Discussion
- Brief Recap: Daniel Mark
09:30-11:00 Putting It All Together: Priorities & Objectives For An Atrial Fibrillation Ablation Safety Registry
- Academic/Professional Society View: David Wilber
- Industry View: Lynette Voshage-Stahl
- FDA View: Thomas Gross
- NIH View: Yves Rosenberg
- Reimbursement View: Mark Grant
- Lead Discussant: Mark Gordon
- Discussion
- Brief Recap: Mark Gordon
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
Adjournment