Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
NCT ID: NCT05797519
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-03-01
2030-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VDyne System Treatment Arm
VDyne Transcatheter Tricuspid Valve Replacement System
The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System.
Interventions
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VDyne Transcatheter Tricuspid Valve Replacement System
The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory.
3. Subject is adequately treated with medical therapy for heart failure \>30 days prior to index procedure, including a diuretic.
4. Heart Team determines patient is a recommended candidate for the VDyne System.
5. Age 18 years or older at time of the index procedure.
6. Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.
Exclusion Criteria
1. Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs, Sponsor and/or Clinical Screening Committee (CSC)
2. Intolerance to procedural anticoagulation or post-procedural antiplatelet/anticoagulation regimen that cannot be medically managed
3. Hypersensitivity to nickel or titanium
4. Left Ventricular Ejection Fraction (LVEF) \<30%
5. Severe RV dysfunction as assessed by the Clinical Screening Committee (CSC).
6. Significant abnormalities of the tricuspid valve and sub-valvular apparatus
7. Sepsis including active infective endocarditis (IE) (within the last 6 months)
8. Right ventricular, atrial thrombus, vegetation or mass on tricuspid valve.
9. Severe tricuspid annular or leaflets calcification
10. Systolic pulmonary hypertension with systolic pulmonary artery pressure \>70 mmHg or pulmonary vascular resistance (PVR) \>5 wood units as determined by RHC.
11. History of rheumatic fever that impacts the native tricuspid valve or surrounding structures.
CONCOMITANT PROCEDURES
12. Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease (CAD).
13. Any planned surgery or interventional procedure within 30 days prior to or following the implant procedure. This includes any planned concomitant cardiovascular procedure \[e.g. Coronary Artery Bypass Grafting (CABG), percutaneous coronary intervention (PCI), pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.\]
14. Unresolved severe symptomatic carotid stenosis (\> 70% by ultrasound)
15. Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.
16. Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.
17. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
18. Prior tricuspid valve surgery or catheter-based therapy with permanent residual device(s) implanted that would preclude delivery or implantation of the VDyne Valve (e.g. valve replacement, edge to edge repair, etc.)
19. Significant valvular heart disease requiring intervention other than the tricuspid valve
20. Known significant intracardiac shunt \[e.g. septal defect), patent foramen ovales (PFOs) without significant shunts are allowed\]
COMORBIDITIES
21. Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure
22. Severe lung disease \[severe chronic obstructive pulmonary disease (COPD) or continuous use of home oxygen or oral steroids\]
23. Acute myocardial infarction (AMI) within 30 days
24. Significant renal dysfunction (eGFR\<30 ml/min/1.73m2) or on dialysis
25. End-stage liver disease (MELD \> 11 and Child-Pugh class C)
26. Bleeding requiring transfusion within 30 days
27. Coagulopathy or other clotting disorder that cannot be medically managed
28. Chronic immunosuppression or other condition that could impair healing response
29. Any of the following: leukopenia, chronic anemia \[Hemoglobin (Hgb) \< 9\], current thrombocytopenia (platelets \<70), history of bleeding diathesis, or coagulopathy
31. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically
32. Life expectancy less than 12 months due to non-cardiac comorbidities
33. Treatment is not expected to provide benefit (futile)
34. Current IV Drug user (must be free drug abuse for \> 1 year)
35. Pregnant, lactating or planning pregnancy during the course of the study
36. Vulnerable patient groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate, such as students, residents, and employees)
37. Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study
38. Patient (or legal guardian) unable or unwilling to provide written informed consent before study-specific procedures are conducted
39. Patient unable or unwilling to comply with study required testing and follow-up visits.
18 Years
ALL
No
Sponsors
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VDyne, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Vinny Podichetty
Role: STUDY_DIRECTOR
VDyne, Inc.
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TPR0038-P
Identifier Type: -
Identifier Source: org_study_id
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