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

Not Applicable

Recruiting

• Conditions: Tricuspid Regurgitation; Tricuspid Valve Disease; Tricuspid Valvular Disorders

• Registration Number: NCT05797519
• Lead Sponsor: VDyne, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-04
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-15
• Last Update Posted: 2025-09-19
• Primary Completion: 2025-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)	30 days post-procedure	The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC).
Change in tricuspid valve regurgitation as measured by the Imaging Core Labs	From Baseline to 1 month post-procedure	Change in tricuspid valve regurgitation as measured by the Imaging Core Labs
Changes in quality of life as measured by the KCCQ changes.	From Baseline to 1 month post-procedure	Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome.
Changes in functional capacity (6-minute walk test)	From Baseline to 1 month post-procedure	Changes in functional capacity (6-minute walk test)
Changes in symptom status (NYHA class)	From Baseline to 1 month post-procedure	Changes in symptom status (NYHA class)

Secondary Outcome Measures

Name	Time	Method
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)	From Baseline to 1 year post-procedure	The percentage of subjects with Device- and/or Procedure related Major Adverse Events as classified by the CEC
Change in tricuspid valve regurgitation as measured by the Imaging Core Lab	From Baseline to 3 months, 6 months and 1 year	Change in tricuspid valve regurgitation as measured by the Imaging Core Lab
Intra-Procedural success	From implant start time to procedure room exit	Rate of successful implantation of the VDyne Valve using the VDyne Delivery System, absence of procedural mortality or stroke, adequate performance of the VDyne Valve, no device-related obstruction of forward flow or pulmonary embolism and \& freedom from emergency surgery or reintervention during the first 24 hours related to the device or access procedure.
Clinical success	From implant to 1 Year post-implant	Improvement from baseline in symptoms (e.g., NYHA improvement by \>1 functional class); and/or Improvement from baseline in functional status (e.g., 6-min walk test improvement by \>30 m); and/or Improvement from baseline in quality-of-life (e.g., Kansas City Cardiomyopathy Questionnaire improvement by \>10)
Changes in symptom status (NYHA class)	From Baseline to 3 months, 6 months and 1 year	Changes in symptom status (NYHA class)
Changes in functional capacity (6 minute walk test)	From Baseline to 3 months, 6 months and 1 year	Changes in functional capacity (6 minute walk test)
Changes in quality of life as measured by the KCCQ changes.	From Baseline to 3 months, 6 months and 1 year	Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome.

Trial Locations

Locations (16)

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

Herz & Diabeteszentrum Nordrhein Westfalen; 🇩🇪 Bad Oeynhausen, Germany

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