Actively Recruiting
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
Led by VDyne, Inc. · Updated on 2025-11-03
120
Participants Needed
21
Research Sites
408 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe or greater tricuspid valve regurgitation of primary or secondary cause
- NYHA class II or higher; if NYHA class IV, patient must be able to walk
- Adequate medical treatment for heart failure including a diuretic for more than 30 days before the procedure
- Recommended candidate for the VDyne System by Heart Team
- Age 18 years or older at the time of the procedure
- Suitability for treatment confirmed by Clinical Screening Committee and Imaging Core Labs
You will not qualify if you...
- Anatomy not suitable for the VDyne System as assessed by experts
- Intolerance to anticoagulation or antiplatelet treatments that cannot be managed
- Allergy to nickel or titanium
- Left ventricular ejection fraction below 30%
- Severe right ventricular dysfunction
- Significant abnormalities of the tricuspid valve or its supporting structures
- Sepsis or infective endocarditis within the past 6 months
- Presence of right heart thrombus, vegetation, or mass on tricuspid valve
- Severe calcification of the tricuspid valve annulus or leaflets
- High pulmonary artery pressure or vascular resistance
- History of rheumatic fever affecting the tricuspid valve or nearby structures
- Significant coronary artery disease requiring treatment
- Planned surgery or intervention within 30 days before or after the implant procedure
- Severe symptomatic carotid artery narrowing over 70%
- Recent cardiac resynchronization or implantable devices within 60 days
- Permanent pacing leads interfering with device implantation
- Cardiogenic shock or hemodynamic instability needing support at implant time
- Previous tricuspid valve surgery or device implantation that prevents VDyne use
- Other significant valvular heart diseases needing intervention
- Known significant intracardiac shunts (except patent foramen ovale without shunt)
- Stroke or transient ischemic attack within 6 months
- Severe lung disease or need for continuous oxygen or steroids
- Recent heart attack within 30 days
- Significant kidney dysfunction or dialysis
- Advanced liver disease
- Recent bleeding requiring transfusion or clotting disorders
- Chronic immunosuppression or conditions impairing healing
- Blood disorders like leukopenia, anemia (hemoglobin <9), thrombocytopenia, or bleeding history
- Unwillingness to receive blood products
- Allergy or contraindication to study medications not manageable
- Life expectancy under 12 months from non-cardiac causes
- Treatment deemed futile
- Current intravenous drug use or recent abuse less than 1 year
- Pregnant, breastfeeding, or planning pregnancy during the study
- Vulnerable groups such as minors, cognitively impaired, prisoners, or those under undue influence
- Participation in other investigational trials that interfere
- Unable or unwilling to provide informed consent
- Unable or unwilling to comply with study procedures and follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
St. Vincent Hospital
Sydney, New South Wales, Australia, 2010
Actively Recruiting
2
Flinders Medical Centre
Adelaide, Australia
Actively Recruiting
3
Princess Alexandra Hospital
Brisbane, Australia
Actively Recruiting
4
The Prince Charles Hospital
Brisbane, Australia
Actively Recruiting
5
Monash Heart
Melbourne, Australia
Actively Recruiting
6
Johannes Kepler University Linz - JKU
Linz, Austria
Actively Recruiting
7
Universitätsklinik für Herzchirurgie Medizinische Universität Wien
Vienna, Austria, 1090
Actively Recruiting
8
AZ Sint Jan Hospital
Bruges, Belgium
Actively Recruiting
9
Nemocnice AGEL Podlesi Trinec
Třinec, Czechia
Actively Recruiting
10
University Hospital of Copenhagen
Copenhagen, Denmark, DK-2100
Actively Recruiting
11
Herz & Diabeteszentrum Nordrhein Westfalen
Bad Oeynhausen, Germany
Actively Recruiting
12
Vivantes Klinik Am Urban
Berlin, Germany, 10967
Actively Recruiting
13
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
14
Universitätsmedizin Rostock
Rostock, Germany, 18057
Actively Recruiting
15
St Antonius Hospital
Nieuwegein, Netherlands
Actively Recruiting
16
Waikato Hospital
Hamilton, Hamilton, New Zealand, 3204
Actively Recruiting
17
Hospital Universitario Puerta de Hierro
Madrid, Spain, 28222
Actively Recruiting
18
Hospital Clínico San Carlos
Madrid, Spain
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19
Lund University Skåne University Hospital
Lund, Sweden
Actively Recruiting
20
Royal Sussex Hospital
Brighton, Sussex, United Kingdom, BN2 1ES
Actively Recruiting
21
Royal Brompton Hospital
London, United Kingdom
Actively Recruiting
Research Team
V
Vinny Podichetty
CONTACT
P
Pree Bassi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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