RecruitingNot ApplicableNCT05797519

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


Sponsor

VDyne, Inc.

Enrollment

120 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called VDyne Transcatheter Tricuspid Valve Replacement System for people with tricuspid regurgitation, tricuspid valve disease, and other related conditions. The study is currently recruiting participants at 21 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVDyne Transcatheter Tricuspid Valve Replacement System

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


Locations(21)

St. Vincent Hospital

Sydney, New South Wales, Australia

Flinders Medical Centre

Adelaide, Australia

Princess Alexandra Hospital

Brisbane, Australia

The Prince Charles Hospital

Brisbane, Australia

Monash Heart

Melbourne, Australia

Johannes Kepler University Linz - JKU

Linz, Austria

Universitätsklinik für Herzchirurgie Medizinische Universität Wien

Vienna, Austria

AZ Sint Jan Hospital

Bruges, Belgium

Nemocnice AGEL Podlesi Trinec

Třinec, Czechia

University Hospital of Copenhagen

Copenhagen, Denmark

Herz & Diabeteszentrum Nordrhein Westfalen

Bad Oeynhausen, Germany

Vivantes Klinik Am Urban

Berlin, Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, Germany

Universitätsmedizin Rostock

Rostock, Germany

St Antonius Hospital

Nieuwegein, Netherlands

Waikato Hospital

Hamilton, Hamilton, New Zealand

Hospital Universitario Puerta de Hierro

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Lund University Skåne University Hospital

Lund, Sweden

Royal Sussex Hospital

Brighton, Sussex, United Kingdom

Royal Brompton Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05797519


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