Why the study?
Following regulatory approvals of transcatheter edge-to-edge repair and tricuspid valve replacement, updated definitions for trial designs and endpoints were needed to compare emerging technologies, tricuspid valve surgery, and medical therapy.
Comparison
Emerging technologies, tricuspid valve surgery, and medical therapy
Design
Consensus document
This TVARC-2 document provides standardized trial design and endpoint definitions to guide future research on transcatheter and surgical interventions for tricuspid regurgitation.
The first Tricuspid Valve Academic Research Consortium publication standardized definitions of disease etiology and severity, as well as standardized endpoints for trials to address the knowledge gaps related to identification and management of patients with tricuspid regurgitation. Based on randomized trials comparing transcatheter tricuspid valve intervention with optimal medical therapy, transcatheter edge-to-edge repair and tricuspid valve replacement were approved by the U.S. Food and Drug Administration and received CE Mark. These technologies represent a major step forward for patients with severe symptomatic tricuspid regurgitation and transcatheter tricuspid valve intervention. This second chapter of the Tricuspid Valve Academic Research Consortium focuses on defining specific trial design and endpoint options for comparisons of emerging technologies, tricuspid valve surgery, and medical therapy.
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Davidson et al. (2026) studied this question. The Tricuspid Valve Academic Research Consortium-2 establishes standardized trial designs and endpoints to compare emerging transcatheter technologies, surgery, and medical therapy.
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