2017 Consensus Summit

ISCTR – TCT 2017 Consensus Summit

Consensus Summit on Clinical Endpoints/Surrogates and Effect Size for Approval of Cardiovascular Devices

(Academia, Industry, Regulatory, Reimbursement, Guideline, and Patients)

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


Standardization of the clinical/surrogate endpoints for cardiovascular device evaluation



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: Blas√© 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.