Clinical Trial

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation

Study acronym: VISTA
Recruiting
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Summary
The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2023-03-21; most recent amendment 2025-10-30.
Trial Details
NCT Number NCT05797519
Lead Sponsor VDyne, Inc.
Conditions Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders
Enrollment 120 participants
Start Date 2023-03-01
Primary Completion 2026-12-30 (estimated)
Study Completion 2030-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-13