Clinical Trial

VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)

Name: VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial) — clinical trial record (NCT07516444)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: TRIVITA

Not Yet Recruiting

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Summary

Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.

Trial Details

NCT Number	NCT07516444
Lead Sponsor	VDyne, Inc.
Conditions	Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases, Tricuspid Valve Insufficiency, Severe Heart Valve Disease, Randomized Controlled Trial (RCT), Symptomatic Tricuspid Regurgitation
Enrollment	730 participants
Start Date	2026-06
Primary Completion	2029-06 (estimated)
Study Completion	2036-06 (estimated)
Updated on ClinicalTrials.gov	2026-04-08