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, Nabil Dib
Clinical Endpoints & Biostatistics
Moderators: Anthony DeMaria, Chris Mullin
Clinical Endpoints/Surrogate & Biostatistics
Roseann White
Endpoints for Clinical Trials for Cardiovascular Devices: Challenges and Solutions
Ori Ben-Yehuda
Valve Disease/Transcatheter Aortic Valve Replacement
Moderators: Martin Leon, Bram Zuckerman
Points of View:
Clinical Scientist: Martin Leon
Industry: Stanton Rowe
Regulatory: Jamie Raben
Payor: Wade Aubry
Practice Guideline: Robert Bonow
Patient: Susan Strong
Valve Disease/Transcatheter Mitral/Tricuspid Valve Repair/Replacement
Moderators: Robert Bonow, Jeroen Bax
Points of View:
Clinical Scientist: John Webb
Industry: Patrick Verta
Regulatory: John Laschinger
Payor: Daniel Canos
Practice Guideline: Blasé Carabello
Patient: Sharon Saeger
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
CHF/Ventricular Assist Devices
Moderators: Ileana Pina, Magdi Yacoub
Points of View:
Clinical Scientist: Keith Aaronson
Industry: Mark Carlson
Regulatory: Jaime Raben
Payor: Daniel Canos
Practice Guideline: Ileana Pina
Patient: Neil Argo
CAD/Coronary Stent
Moderators: David Holmes, Gregg Stone
Points of View:
Clinical Scientist: Gregg Stone
Industry: Charles Simonton
Regulatory: Andrew Farb
Payor: Jack Lewin
Practice Guideline: Alice Jacobs
Patient: John Dominguez
Arrhythmia/Catheter Ablation
Moderators: Marco Cannella, Douglas Packer
Points of View:
Clinical Scientist: Douglas Packer
Industry: Anthony Hong
Regulatory: Marco Cannella
Payor: Wade Aubry
Practice Guideline: Vivek Reddy
Patient: Larry Haffner
Consensus on Clinical Endpoints Discussion and Action Items
Moderators: Bram Zuckerman, Nabil Dib
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.