clinical trial · NCT07516444
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)
VDyne, Inc.·N/A·not yet recruiting·n = 730
Tricuspid Valve RegurgitationTricuspid Valve DiseaseCardiovascular Diseases (CVD)Heart Valve DiseasesTricuspid Valve InsufficiencySevere Heart Valve DiseaseRandomized Controlled Trial (RCT)Symptomatic Tricuspid RegurgitationTranscatheter Tricuspid Valve Replacement (TTVR) with VDyne SystemTranscatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System
brief summary
Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.
started
Jun 1, 2026
primary completion
Jun 1, 2029
completion
Jun 1, 2036
last updated
Apr 8, 2026
detailed description
The clinical trial is a prospective, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.
official title
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol