Evaluating a new device for treating tricuspid regurgitation

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

This study is testing a new device to see if it can safely help people with moderate to severe tricuspid regurgitation feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: VDyne, Inc. (Industry-sponsored)
• Locations: 21 sites (Sydney, New South Wales and 20 other locations)
• Trial ID: NCT05797519 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the safety and effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement System in patients suffering from moderate to severe tricuspid regurgitation. Participants will be evaluated to ensure they meet specific criteria, including adequate medical therapy for heart failure prior to the procedure. The study will involve a thorough assessment of patient anatomy and suitability for the device by a Clinical Screening Committee and Imaging Core Labs. The goal is to determine if this innovative approach can improve outcomes for patients with tricuspid valve disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe tricuspid regurgitation who have been adequately treated with heart failure medications.

Not a fit: Patients with unsuitable cardiac anatomy for the VDyne System or severe right ventricular dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with tricuspid regurgitation.

How similar studies have performed: While this specific approach is novel, similar transcatheter valve replacement methods have shown promise in treating other valvular heart diseases.

Eligibility criteria

Inclusion Criteria:

1. Severe or greater tricuspid valve regurgitation of primary or secondary etiology.
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:

VDYNE SYSTEM SUITABILITY

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

   CLINICAL EXCLUSION CRITERIA (assessed by pre-procedural imaging)
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
30. Unwilling to receive blood products GENERAL EXCLUSION CRITERIA
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.

Where this trial is running

Sydney, New South Wales and 20 other locations

• St. Vincent Hospital — Sydney, New South Wales, Australia (Recruiting)
• Flinders Medical Centre — Adelaide, Australia (Recruiting)
• Princess Alexandra Hospital — Brisbane, Australia (Recruiting)
• The Prince Charles Hospital — Brisbane, Australia (Recruiting)
• Monash Heart — Melbourne, Australia (Recruiting)
• Johannes Kepler University Linz - JKU — Linz, Austria (Recruiting)
• Universitätsklinik für Herzchirurgie Medizinische Universität Wien — Vienna, Austria (Recruiting)
• AZ Sint Jan Hospital — Bruges, Belgium (Recruiting)
• Nemocnice AGEL Podlesi Trinec — Třinec, Czechia (Recruiting)
• University Hospital of Copenhagen — Copenhagen, Denmark (Recruiting)
• Herz & Diabeteszentrum Nordrhein Westfalen — Bad Oeynhausen, Germany (Recruiting)
• Vivantes Klinik Am Urban — Berlin, Germany (Recruiting)
• Universitätsklinikum Schleswig-Holstein, Campus Kiel — Kiel, Germany (Recruiting)
• Universitätsmedizin Rostock — Rostock, Germany (Recruiting)
• St Antonius Hospital — Nieuwegein, Netherlands (Recruiting)
• Waikato Hospital — Hamilton, Hamilton, New Zealand (Recruiting)
• Hospital Universitario Puerta de Hierro — Madrid, Spain (Recruiting)
• Hospital Clínico San Carlos — Madrid, Spain (Recruiting)
• Lund University Skåne University Hospital — Lund, Sweden (Recruiting)
• Royal Sussex Hospital — Brighton, Sussex, United Kingdom (Recruiting)
• Royal Brompton Hospital — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Vinny Podichetty

Conditions Tricuspid Regurgitation; Tricuspid Valve Disease; Tricuspid Valvular Disorders