Tricuspid Valve Academic Research Consortium-2 (TVARC-2): Trial Design and Endpoints
In this preplanned Tricuspid Valve Academic Research Consortium-2 (TVARC-2) consensus document, we seek to utilize the definitions and principles described in TVARC-1 to create Chapter 2. Specifically, TVARC-2 proposes trial designs and endpoints to inform future transcatheter tricuspid valve intervention investigation.
Modernizing the Data Infrastructure for Clinical Research
Michael Mack and Amy Abernathy discuss how to streamline research and accelerate timelines in order to provide timely care.
Challenges of Long-Term Follow-Up
Sreek Vemulapalli and Roseann White explain the statistical challenges that can arise while collecting longer-term follow-up data during clinical trials.
Optimizing Long-Term Follow-Up
Sreekanth Vemulapalli asks Ryan Ahern about potential data sources that can be used to sustain long-term follow-up in pivotal trials.
Minimum Core Data Elements for Evaluation of TAVR: A Scientific Statement by PASSION CV, HVC, and TVT Registry
This systematic review of the published research for high-impact transaortic valve replacement (TAVR) studies and U.S. multicenter, multidevice registries resulted in 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence.
Long-Term Follow-Up of Patients with Heart Valve Devices Workshop [Sneak Peek]
Overview of FDA-Mandated Long-Term Post-approval Studies for Heart Valve Devices — Lisa Plummer, RN, MSN