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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05797519




Registration number
NCT05797519
Ethics application status
Date submitted
6/03/2023
Date registered
4/04/2023

Titles & IDs
Public title
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
Scientific title
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
Secondary ID [1] 0 0
TPR0038-P
Universal Trial Number (UTN)
Trial acronym
VISTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tricuspid Regurgitation 0 0
Tricuspid Valve Disease 0 0
Tricuspid Valvular Disorders 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - VDyne Transcatheter Tricuspid Valve Replacement System

Experimental: VDyne System Treatment Arm -


Treatment: Devices: VDyne Transcatheter Tricuspid Valve Replacement System
The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)
Timepoint [1] 0 0
30 days post-procedure
Primary outcome [2] 0 0
Mortality
Timepoint [2] 0 0
30 days post-procedure
Primary outcome [3] 0 0
Device success
Timepoint [3] 0 0
From implant start time to procedure room exit
Primary outcome [4] 0 0
Procedural success
Timepoint [4] 0 0
From implant start time to procedure room exit
Primary outcome [5] 0 0
Change in tricuspid valve regurgitation as measured by the Imaging Core Labs
Timepoint [5] 0 0
From Baseline to 1 month post-procedure
Primary outcome [6] 0 0
Changes in quality of life as measured by the KCCQ changes.
Timepoint [6] 0 0
From Baseline to 1 month post-procedure
Primary outcome [7] 0 0
Changes in functional capacity (6-minute walk test)
Timepoint [7] 0 0
From Baseline to 1 month post-procedure
Primary outcome [8] 0 0
Changes in symptom status (NYHA class)
Timepoint [8] 0 0
From Baseline to 1 month post-procedure
Secondary outcome [1] 0 0
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)
Timepoint [1] 0 0
From Baseline to 1 year post-procedure
Secondary outcome [2] 0 0
Change in tricuspid valve regurgitation as measured by the Imaging Core Lab
Timepoint [2] 0 0
From Baseline to 3 months, 6 months and 1 year
Secondary outcome [3] 0 0
Rate of heart failure hospitalization
Timepoint [3] 0 0
From Baseline to 3 months, 6 months and 1 year
Secondary outcome [4] 0 0
Changes in symptom status (NYHA class)
Timepoint [4] 0 0
From Baseline to 3 months, 6 months and 1 year
Secondary outcome [5] 0 0
Changes in functional capacity (6 minute walk test)
Timepoint [5] 0 0
From Baseline to 3 months, 6 months and 1 year
Secondary outcome [6] 0 0
Changes in quality of life as measured by the KCCQ changes.
Timepoint [6] 0 0
From Baseline to 3 months, 6 months and 1 year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2029
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St. Vincent Hospital - Sydney
Recruitment hospital [2] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [5] 0 0
Monash Heart - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Czechia
State/province [2] 0 0
Prague
Country [3] 0 0
Czechia
State/province [3] 0 0
Trinec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
VDyne, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Laura Moffett
Address 0 0
VDyne, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Laura Moffett
Address 0 0
Country 0 0
Phone 0 0
+1.952.303.2821
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is not a plan to make IPD available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05797519