STS Summer Series: Clinical Research in Valvular Heart Disease during COVID: Adapting to a Dynamic and Multifaceted Pandemic

The COVID pandemic has caused major disruptions in clinical care and clinical research, including early feasibility, pivotal, and post-approval trials for valvular heart disease (VHD). In this webinar, STS/ACC TVT Registry leaders—Vinod H. Thourani, MD, and John D. Carroll, MD—spoke with investigators, representatives from the Food and Drug Administration (FDA), and industry about the clinical research disruption and how to mitigate its negative impacts. 

They discussed:

  • Balancing COVID safety with the consequences of delayed VHD treatment 
  • Disruptions in resources, personnel, scheduling, and finances
  • Developing strategies for regional variations in the COVID curve 
  • Advantages and limitations of telehealth for research efforts
  • Managing new patient enrollment and retention, as well as best COVID prevention and testing practices
  • Changes in regulatory, reimbursement, and ethical oversight of clinical trials


This episode was cosponsored by the American College of Cardiology.

The episode is also available as a podcast.

 
Moderators

John D. Carroll, MD
University of Colorado
Aurora, CO

Vinod H. Thourani, MD
Piedmont Heart Institute
Atlanta, GA 

 

Panelists

Dominic J. Allocco, MD  
Boston Scientific
Maple Grove, MN

Andrew Farb, MD
Food and Drug Administration
Silver Spring, MD

Susheel K. Kodali, MD
NewYork-Presbyterian/Columbia University Medical Center
New York, NY

Michael J. Mack, MD
Baylor Scott & White Health
Plano, TX

Mark Reisman, MD
UW Medicine
Seattle, WA

Barathi Sethuraman, PhD 
Abbott
Santa Clara, CA

Changfu Wu, PhD
Food and Drug Administration
Silver Spring, MD

Bram D. Zuckerman, MD
Food and Drug Administration
Silver Spring, MD