Summit on Clinical Endpoints/Surrogates and Effect Size for Approval of Cardiovascular Devices (Academia, Industry, Regulatory, Reimbursement, Guideline, and Patients)
ISCTR - TCT 2017 Summit
Sunday, October 29, 2017
Colorado Convention Center, Four Seasons Ballroom 4
Denver, Colorado
8:30 am - 5:00 pm
Course Directors: Nabil Dib, Bram Zuckerman, Spencer King, and Martin Leon
Objective
Standardization of the clinical/surrogate endpoints for cardiovascular device evaluation
Introduction
Welcome and ISCTR Mission Statement and Introduction
Spencer King View Presentation, Nabil Dib View Presentation
Clinical Endpoints & Biostatistics
Moderators: Anthony DeMaria, Chris Mullin View Presentation
Clinical Endpoints/Surrogate & Biostatistics
Roseann White View Presentation
Endpoints for Clinical Trials for Cardiovascular Devices: Challenges and Solutions
Ori Ben-Yehuda View Presentation
Valve Disease/Transcatheter Aortic Valve Replacement
Moderators: Martin Leon, Bram Zuckerman View Presentation
Points of View:
Clinical Scientist: Martin Leon View Presentation
Industry: Stanton Rowe View Presentation
Regulatory: Jamie Raben View Presentation
Payor: Wade Aubry View Presentation
Practice Guideline: Robert Bonow View Presentation
Patient: Susan Strong View Presentation
Valve Disease/Transcatheter Mitral/Tricuspid Valve Repair/Replacement
Moderators: Robert Bonow, Jeroen Bax View Presentation
Points of View:
Clinical Scientist: John Webb View Presentation
Industry: Patrick Verta View Presentation
Regulatory: John Laschinger View Presentation
Payor: Daniel Canos View Presentation
Practice Guideline: Blasé Carabello View Presentation
Patient: Sharon Saeger View Presentation
Award Presentation and Keynote Address
Presentation of the Glen and Marilyn Nelson Award for Innovation and Translation in Cardiovascular Medicine
Marilyn Nelson, Spencer King
Keynote Address: Ventricular Assist Devices, the Windy Road to Recovery
Sir Professor Magdi Yacoub, Nelson Award Recipient View Presentation
CHF/Ventricular Assist Devices
Moderators: Ileana Pina, Magdi Yacoub View Presentation
Points of View:
Clinical Scientist: Keith Aaronson View Presentation
Industry: Mark Carlson View Presentation
Regulatory: Jaime Raben View Presentation
Payor: Daniel Canos View Presentation
Practice Guideline: Ileana Pina View Presentation
Patient: Neil Argo View Presentation
CAD/Coronary Stent
Moderators: David Holmes, Gregg Stone View Presentation
Points of View:
Clinical Scientist: Gregg Stone View Presentation
Industry: Charles Simonton View Presentation
Regulatory: Andrew Farb View Presentation
Payor: Jack Lewin View Presentation
Practice Guideline: Alice Jacobs View Presentation
Patient: John Dominguez View Presentation
Arrhythmia/Catheter Ablation
Moderators: Marco Cannella, Douglas Packer View Presentation
Points of View:
Clinical Scientist: Douglas Packer View Presentation
Industry: Anthony Hong View Presentation
Regulatory: Marco Cannella View Presentation
Payor: Wade Aubry View Presentation
Practice Guideline: Vivek Reddy View Presentation
Patient: Larry Haffner View Presentation
Consensus on Clinical Endpoints Discussion and Action Items
Moderators: Bram Zuckerman, Nabil Dib View Presentation
Discussants: Anthony DeMaria, David Holmes, Alan Fraser, Charles Simonton, Stan Rowe, Douglas Packer, Andrew Farb,
Ileana Pina, Mark Toland, Patrick Verta, Jack Lewin, Alan Balch, Jeroen Bax, Spencer King, Wade Aubry, Robert
Roberts
Panel discussions will conclude each session.