National Registry on Safety & Atrial Fibrillation Ablation: 

An Incubator Thinktank

April 27-28, 2009

FDA White Oak Campus Conference Center

10903 New Hampshire Avenue

Silver Spring, MD 20993

Presentations, agendas, and other material pertinent to the recently concluded 2009 Atrial Fibrillation Ablation Thinktank are provided below.

[All files are in Adobe Acrobat PDF format. Download the free Acrobat Reader program.]

Day 1 - Monday 27 April 2009

07:00-07:30 Registration & Continental Buffet

07:45-09:45 Opening Session

• Introduction of Attendees & Brief Welcomes (10 min):

CSRC/DCRI: Mitchell Krucoff

FDA: Daniel Schultz

ACC: Janet Wright

HRS: Stephen Hammill

Industry: Ruey Dempsey

• Anatamy of a Cardiac Safety Thinktank (5 min): Mitchell Krucoff

Plenary Presentations

• "Concept, Challenges, Uptake & Adoption of Atrial Fibrillation Ablation:

• Academic View (10 min): Douglas Packer

• FDA View (10 min): Randall Brockman

• Pharma Industry View (10 min): David Feigal

• Device Industry View (10 min): Marcia Yaross

• National Registries & Federal Paradigms and Lessons Learned: (60 min; 10 min ea)

• 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: Mitchel 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 (5 min): Hugh Calkins
• Academic View: Technique (5 min): Kenneth Ellenbogen
• Industry View: Imaging and Technique (10 min): Jay Millerhagen
• FDA View: Imaging and Technique (10 min): Jun Dong
• Lead Discussant (2 min): Eric Prystowsky
• Discussion (35 min)
• Brief Recap (5 min): Eric Prystowsky

11:00-11:15 Break

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

• Industry View (5 min): Julie Broderick
• FDA View (5 min): Felipe Aguel
• Academic/Professional Society View (5 min): Andrea Natale
• CMS View (5 min): Marcel Salive
• NIH View (5 min): Alice Mascette
• Lead Discussant (2 min): Phillip Sager
• Discussion (35 min)
• Brief Recap (5 min): Phillip Sager

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

• Academic/Professional Society View (5 min): Sana Al-Khatib
• FDA View (5 min): Ellen Pinnow
• Industry View (5 min): Lynette Voshage-Stahl
• Lead Discussant (2 min): Mitchell Magee
• Discussion (15 min)
• Brief Recap (5 min): 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 (5 min): James Reiffel
• Industry View (5 min): Andrew Koren
• FDA View (5 min): Norman Stockbridge

Monitoring

• Academic View (5 min): Albert Waldo
• Industry View (5 min): Jay Millerhagen
• FDA View (5 min): Randall Brockman
• Lead Discussant (2 min): Peter Kowey
• Discussion (50 min)
• Brief Recap (5 min): 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 (5 min): Stephen Hammill
• Industry View (5 min): Ruey Dempsey
• FDA View (5 min): Wendy Sanhai
• NIH View (5 min): Yves Rosenberg
• Lead Discussant (2 min): Benjamin Eloff
• Discussion (60 min)
• Brief Recap (5 min): Benjamin Eloff

17:00-17:30 Summarizing Day 1 (5 min each)

• Industry Perspective: Marcia Yaross
• FDA Perspective: Elias Mallis
• Academic Perspective: Peter Kowey
• CSRC Perspective: Mitchell Krucoff
• Professional Society Perspective: Eric Prystowsky
• Adjournment of Day

Day 2 - Tuesday 28 April 2009

07:30-08:00 Continental Breakfast

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

Statistics

• Academic View (5 min): Kerry Lee
• Industry View (5 min): Dan Schaber
• FDA View (5 min): Daniel Canos

Processes & Publications

• Academic View (5 min): Richard Page
• Industry View (5 min): John Finkle
• FDA View (5 min): Benjamin Eloff
• Lead Discussant (2 min): Daniel Mark
• Discussion (45 min)
• Brief Recap (5 min): Daniel Mark

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

• Academic/Professional Society View (5 min): David Wilber
• Industry View (5 min): Lynette Voshage-Stahl
• FDA View (5 min): Thomas Gross
• NIH View (5 min): Yves Rosenberg
• Reimbursement View (5 min): Mark Grant
• Lead Discussant (2 min): Mark Gordon
• Discussion (50 min)
• Brief Recap (5 min): Mark Gordon

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

• Industry View (5 min): Burke Barrett
• FDA View (5 min): Bram Zuckerman
• Academic/Professional Society View (5 min): Peter Kowey
• NIH View (5 min): Alice Mascette
• Insurance Industry View (5 min): Mark Grant
• CMS View (5 min): Marcel Salive
• Lead Discussant (2 min): Richard Page
• Discussion (40 min)
• Adjournment