February 25, 2023
1:00-1:10 Welcome
Norman Stockbridge (U.S. FDA CDER); Bram Zuckerman (U.S. FDA CDRH)
1:10 – 3:10 Session I: CSRC Shock Program Updates
• Shock-ARC (SHARC) Working Group View Recording Here
Moderators: Ron Waksman (Washington Heart Center)
1:10-1:20 Program Update: William Abraham (Ohio State) View Slides
1:20-1:40 Panel Discussion: Don Cutlip (Baim/ARC); Alexandre Mebazaa (Université Paris Cité); Charles Simonton (Abiomed); Ernest Spitzer (Cardialysis/ARC)
• Shock Resources Working Group: AHA Shock Registry View Recording Here
Moderators: Ileana Pina (Montefiore/FDA); Andres Beiras (Getinge)
1:40-1:50 Program Update: Mariell Jessup (AHA) View Slides
1:50-2:10 Panel Discussion: David Morrow (Harvard/Brigham & Women’s); Nicole Gillette (U.S. FDA); Robert Kormos (Abbott)
• Informed Consent for Shock Studies Working Group View Recording Here
Moderators: John Sapirstein (U.S. FDA); Navin Kapur (Tufts)
2:10-2:20 Program Update: Nick West (Abbott) View Slides
2:20-2:40 Panel Discussion: Graham Nichol (University of Washington); Pablo Morales (U.S. FDA); Holger Thiele (FESC Heart Center Leipzig)
• Priorities for Collaborative Efforts and Cardiogenic Shock Going Forward View Recording Here
Moderators: Ian Gilchrist (Hershey); Mauro Moscucci (U.S. FDA)
2:40-2:50: FDA Perspective: Mauro Moscucci (U.S. FDA) View Slides
2:50-3:10: Panel Discussion: Navin Kapur (Tufts); Eric Vang (Medtronic); Wayne Batchelor (Inova); Ileana Pina (U.S. FDA)
3:10-3:30 BREAK
3:30 – 5:20 Session II: Roundtable On Making Prospective RCT Shock Studies Less Burdensome
Moderators: Bram Zuckerman; Mitchell Krucoff (Duke University)
• 3:30-3:40 Academic Perspective: Navin Kapur (Tufts) View Slides | View Recording Here
• 3:40-3:50 Regulatory Perspective: Rebecca Torguson (U.S. FDA) View Slides | View Recording Here
• 3:50-4:00 Professional Society Perspective: Mariell Jessup (AHA) View Recording Here
• 4:00-5:20 Panel Discussion: David Morrow (Harvard/Brigham & Women’s); Nicole Gillette (U.S. FDA); Wayne Batchelor (Inova); Robert Kormos (Abbott); Pablo Morales (U.S. FDA); Charles Simonton (Abiomed); Holger Thiele (FESC Heart Center Leipzig); Ron Waksman (Washington Heart Center)
5:20-5:30 Adjournment