Why the study?
Following recent clinical trials and approvals of transcatheter tricuspid valve interventions, updated consensus was needed to define trial design and endpoint options for comparisons among emerging technologies, surgery, and medical therapy.
Design
Academic Research Consortium consensus statement
Standardized TVARC definitions and endpoints support FDA approval of TEER and TVR; extends trial framework for tricuspid regurgitation research.
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.
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