Clinical Trial

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)

Study acronym: VISTA-US
Recruiting
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Summary
The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).
Protocol Amendment History 1 change
minor Completion pushed: 2030-11-30 -> 2031-11-30 2026-04-01
Trial Details
NCT Number NCT05848284
Lead Sponsor VDyne, Inc.
Conditions Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders
Enrollment 30 participants
Start Date 2024-04-01
Primary Completion 2026-11-30 (estimated)
Study Completion 2031-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-31