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

Tricuspid Regurgitation Clinical Trial

— VISTA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797519
• Other study ID #: TPR0038-P
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: September 30, 2029

Study information

• Verified date: May 2024
• Source: VDyne, Inc.
• Contact: Laura Moffett
• Phone: +1.952.303.2821
• Email: lmoffett[@]vdyne.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2029
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Disease
• Tricuspid Valve Insufficiency

Intervention

Device:
• VDyne Transcatheter Tricuspid Valve Replacement System
The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System.

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide
Australia	Princess Alexandra Hospital	Brisbane
Australia	The Prince Charles Hospital	Brisbane
Australia	Monash Heart	Melbourne
Australia	St. Vincent Hospital	Sydney	New South Wales
Austria	Johannes Kepler University Linz - JKU	Linz
Czechia	Na Homolce Hospital	Prague
Czechia	Nemocnice AGEL Podlesi Trinec	Trinec

Sponsors (1)

Lead Sponsor	Collaborator
VDyne, Inc.

Countries where clinical trial is conducted

Australia,  Austria,  Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)	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).	30 days post-procedure
Primary	Mortality	Mortality will be reported at 30 days post-procedure	30 days post-procedure
Primary	Device success	Rate of successful implantation of the VDyne Valve using the VDyne Delivery System	From implant start time to procedure room exit
Primary	Procedural success	Rate of successful implantation of the VDyne Valve using the VDyne Delivery System & freedom from serious device and/or procedure-related adverse events	From implant start time to procedure room exit
Primary	Change in tricuspid valve regurgitation as measured by the Imaging Core Labs	Change in tricuspid valve regurgitation as measured by the Imaging Core Labs	From Baseline to 1 month post-procedure
Primary	Changes in quality of life as measured by the KCCQ changes.	Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome.	From Baseline to 1 month post-procedure
Primary	Changes in functional capacity (6-minute walk test)	Changes in functional capacity (6-minute walk test)	From Baseline to 1 month post-procedure
Primary	Changes in symptom status (NYHA class)	Changes in symptom status (NYHA class)	From Baseline to 1 month post-procedure
Secondary	The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)	The percentage of subjects with Device- and/or Procedure related Major Adverse Events as classified by the CEC	From Baseline to 1 year post-procedure
Secondary	Change in tricuspid valve regurgitation as measured by the Imaging Core Lab	Change in tricuspid valve regurgitation as measured by the Imaging Core Lab	From Baseline to 3 months, 6 months and 1 year
Secondary	Rate of heart failure hospitalization	Rate of heart failure hospitalization	From Baseline to 3 months, 6 months and 1 year
Secondary	Changes in symptom status (NYHA class)	Changes in symptom status (NYHA class)	From Baseline to 3 months, 6 months and 1 year
Secondary	Changes in functional capacity (6 minute walk test)	Changes in functional capacity (6 minute walk test)	From Baseline to 3 months, 6 months and 1 year
Secondary	Changes in quality of life as measured by the KCCQ changes.	Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome.	From Baseline to 3 months, 6 months and 1 year