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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
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement System for treating tricuspid regurgitation, a heart valve disorder. The study aims to gather data to support the device's approval under Conformité Européenne (CE) marking. This clinical investigation is led by VDyne, Inc. and focuses on adults with severe tricuspid valve problems who are candidates for this treatment. Participants will receive treatment using the VDyne System, a device designed to replace the tricuspid valve via a minimally invasive procedure. The study includes one treatment group using this system. Key assessments will occur from baseline to one month after the procedure, with extended follow-up up to one year to track device-related major adverse events, valve function, quality of life, symptom status, and physical capacity. Throughout the study, participants will undergo imaging evaluations, functional tests like the 6-minute walk test, and quality of life questionnaires. Researchers will monitor safety and effectiveness at multiple time points, including 30 days, 3 months, 6 months, and one year after the procedure. The total duration of participation varies, with ongoing assessments to ensure comprehensive data collection and patient monitoring.
CONDITIONS
Brief 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 ambulatory
- Treated with medical therapy for heart failure including diuretics for more than 30 days prior to procedure
- Recommended candidate for the VDyne System by a Heart Team
- Age 18 years or older at time of procedure
- Suitability for VDyne System confirmed by Clinical Screening Committee and Imaging Core Labs
You will not qualify if you...
- Unsuitable cardiac or vascular anatomy for the VDyne System
- Intolerance to procedural or post-procedural anticoagulation that cannot be managed
- Hypersensitivity to nickel or titanium
- Left ventricular ejection fraction below 30%
- Severe right ventricular dysfunction
- Significant abnormalities of tricuspid valve or sub-valvular structures
- Active or recent sepsis or infective endocarditis within 6 months
- Presence of right heart thrombus, vegetation, or mass on tricuspid valve
- Severe calcification of tricuspid annulus or leaflets
- Severe pulmonary hypertension with specified pressures or resistance
- History of rheumatic fever impacting tricuspid valve or surrounding structures
- Significant coronary artery disease requiring treatment
- Planned cardiovascular surgery or intervention within 30 days before or after implant
- Severe symptomatic carotid stenosis over 70%
- Cardiac devices implanted within 60 days interfering with VDyne delivery
- Cardiogenic shock or instability requiring inotropes or mechanical support
- Prior tricuspid valve surgery or device therapy preventing VDyne implantation
- Significant valvular heart disease needing intervention other than tricuspid valve
- Significant intracardiac shunts excluding patent foramen ovale without shunts
- Recent stroke or transient ischemic attack within 6 months
- Severe lung disease or continuous oxygen/steroid use
- Recent heart attack within 30 days
- Severe kidney dysfunction or dialysis
- End-stage liver disease with high MELD or Child-Pugh class
- Recent bleeding requiring transfusion or clotting disorders
- Immunosuppression or conditions impairing healing
- Low blood counts or bleeding disorders
- Unwillingness to receive blood products
- Hypersensitivity to procedural medications
- Life expectancy under 12 months due to non-cardiac illness
- Treatment expected to be futile
- Current intravenous drug use or recent abuse
- Pregnancy, breastfeeding, or planning pregnancy during study
- Vulnerable populations including minors and cognitively impaired
- Participation in conflicting investigational drug or device trials
- Inability or unwillingness to provide informed consent
- Inability or unwillingness to comply with study testing and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Procedure day
Participants undergo implantation of the VDyne Transcatheter Tricuspid Valve Replacement System.
1 procedure visit (in-person)
Duration - Up to 1 year post-procedure
Participants are monitored for safety, symptom status, and valve function after the procedure.
Visits at 1 month, 3 months, 6 months, and 1 year post-procedure (in-person)
Trial Site Locations
Total: 21 locations
1
St. Vincent Hospital
Sydney, New South Wales, Australia, 2010
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2
Flinders Medical Centre
Adelaide, Australia
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3
Princess Alexandra Hospital
Brisbane, Australia
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4
The Prince Charles Hospital
Brisbane, Australia
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5
Monash Heart
Melbourne, Australia
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6
Johannes Kepler University Linz - JKU
Linz, Austria
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7
Universitätsklinik für Herzchirurgie Medizinische Universität Wien
Vienna, Austria, 1090
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8
AZ Sint Jan Hospital
Bruges, Belgium
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9
Nemocnice AGEL Podlesi Trinec
Třinec, Czechia
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10
University Hospital of Copenhagen
Copenhagen, Denmark, DK-2100
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11
Herz & Diabeteszentrum Nordrhein Westfalen
Bad Oeynhausen, Germany
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12
Vivantes Klinik Am Urban
Berlin, Germany, 10967
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13
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
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14
Universitätsmedizin Rostock
Rostock, Germany, 18057
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15
St Antonius Hospital
Nieuwegein, Netherlands
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16
Waikato Hospital
Hamilton, Hamilton, New Zealand, 3204
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17
Hospital Universitario Puerta de Hierro
Madrid, Spain, 28222
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18
Hospital Clínico San Carlos
Madrid, Spain
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19
Lund University Skåne University Hospital
Lund, Sweden
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20
Royal Sussex Hospital
Brighton, Sussex, United Kingdom, BN2 1ES
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21
Royal Brompton Hospital
London, United Kingdom
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Research Team
V
Vinny Podichetty
P
Pree Bassi
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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