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

The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of moderate to severe tricuspid regurgitation (TR).


Eligibility Criteria:
Inclusion Criteria:

1. Moderate or severe tricuspid valve regurgitation of primary or secondary etiology.
2. Subject is adequately treated with medical therapy for heart failure 30 days prior to index procedure, including a diuretic.
3. Heart Team determines patient is a recommended candidate for the VDyne System.
4. Age 18 years or older.
5. 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 Clinical Screening Committee
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
6. Significant abnormalities of the tricuspid valve and sub-valvular apparatus.
7. Sepsis including active infective endocarditis (IE) (within last 6 months)
8. Right ventricular or atrial thrombus or vegetation
9. Severe tricuspid annular or leaflets calcification
10. Systolic pulmonary hypertension with systolic pulmonary artery pressure ≥70 mmHg.

    History of rheumatic fever

    CONCOMITANT PROCEDURES
11. Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease.
12. Any planned surgery or interventional procedure within the period of 30 days prior to 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as CABG, PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc
13. Unresolved severe symptomatic carotid stenosis (\> 70% by ultrasound)
14. Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.
15. Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.
16. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure
17. Prior tricuspid valve surgery or catheter-based therapy with permanent residual devices implanted that would preclude delivery or implantation of the VDyne Valve (e.g. valve replacement, edge to edge repair.)
18. Severe valvular heart disease requiring intervention other than the tricuspid valve
19. Known significant intracardiac shunt (e.g. septal defect) (PFO's without significant shunts are allowed)

    COMORBIDITIES
20. Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure
21. Severe lung disease (severe COPD or continuous use of home oxygen or oral steroids)
22. Acute myocardial infarction (AMI) within 30 days
23. Significant renal dysfunction (eGFR\<30 ml/min/1.73m2) or on dialysis
24. End-stage liver disease (MELD \> 11 / CHILD class C)
25. Bleeding requiring transfusion within 30 days
26. Coagulopathy or other clotting disorder that cannot be medically managed
27. Chronic immunosuppression or other condition that could impair healing response
28. Any of the following: leukopenia, chronic anemia (Hgb \< 9), thrombocytopenia, history of bleeding diathesis, or coagulopathy
29. Unwilling to receive blood products

    GENERAL EXCLUSION CRITERIA
30. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically
31. Life expectancy less than 12 months due to non-cardiac comorbidities
32. Treatment is not expected to provide benefit (futile)
33. Current IV Drug user (must be free drug abuse for \> 1 year)
34. Pregnant, lactating or planning pregnancy within next 12 months. (Female of child-bearing potential use two reliable contraceptive methods during the study - hormonal methods such as pill and condom).
35. 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)
36. Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study
37. Patient (or legal guardian) unable or unwilling to provide written informed consent before study-specific procedures are conducted
38. Patient unable or unwilling to comply with study required testing and follow-up visits.
39. Rhuematic fever