iCVCT 1. Interventional Clinical Trials in the Time of COVID: Challenges (...)

Saturday, December 5th: 1:30 – 3:30 pm

iCVCT 1. Interventional Clinical Trials in the Time of COVID: Challenges for Device Studies in Interventional Therapies

Are you tired of talking about the COVID-19 pandemic? Aren’t we all? But how are you dealing with the challenges in completing or initiating interventional trials to assess CV devices? Interventional clinical trials present all of the safety, and follow-up issues discussed in some of the other sessions on conducting trials during this pandemic, but have the added challenge of requiring patients to come in to hospitals that can be over-taxed and high-risk environments.

This session will be chaired by Dr. Michael Gibson and Dr. Roxana Mehran. Dr. Gibson is an interventional cardiologist, at the Beth Israel Deaconess Medical Center in Boston MA, USA, and the founder of PERFUSE, an academic research organization providing clinical trial management services. Dr. Mehran is the Director of the Center for Interventional Cardiovascular Research and Clinical Trials at Mount Sinai and founder of the Cardiovascular Research Foundation in New York, NY, USA.

The aim of this session is to provide practical advice and strategies to help ensure that general CV and trial-related care are not compromised, and that safe and effective care is delivered to trial participants without affecting the integrity of the study. We will hear perspectives from trialists (Dr. Gibson), industry (Jennifer Jones, Abbott Vascular, USA) and regulatory speakers (Bram Zuckerman, FDA, USA)

The moderated, multi-stakeholder, expert panel debate titled “Challenges for Device Trials

in the Time of COVID - Quick Fix and Enduring Changes” will be a larger forum for people to present their challenges, offer or find solutions, and look to the future.