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

NCT05797519 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-11-03

No results posted yet for this study

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.

Conditions

  • Tricuspid Regurgitation
  • Tricuspid Valve Disease
  • Tricuspid Valvular Disorders

Interventions

DEVICE

VDyne Transcatheter Tricuspid Valve Replacement System

The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System.

Sponsors & Collaborators

  • VDyne, Inc.

    lead INDUSTRY

Principal Investigators

  • Vinny Podichetty · VDyne, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2026-12-30
Completion
2030-12-30
FDA Device
Yes

Countries

  • Australia
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Germany
  • Netherlands
  • New Zealand
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05797519 on ClinicalTrials.gov