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  /  ISCTR – TCT 2017 Summit
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.