If this is close to home

This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.

Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
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Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14

Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.

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Study for people with Heart Disease

Recruiting Not a phased study

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Not a phased study

Sponsor VDyne, Inc.

Registry number NCT05797519

Started 1 March 2023 Today 16 October 2026 Estimated completion 30 December 2026

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
St. Vincent Hospital	Sydney	NSW	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

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 120

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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.

Dates on the record

Started 1 March 2023

Estimated completion 30 December 2026

Registry last updated 13 August 2026

Checked by Voxsanity 11 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 13 August 2026.
This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT05797519

Sponsor: VDyne, Inc.

Phase: Not a phased study

Status: Recruiting

Condition: Heart Disease

More information: https://clinicaltrials.gov/study/NCT05797519

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

Severe or greater tricuspid valve regurgitation of primary or secondary etiology.
NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory.
Subject is adequately treated with medical therapy for heart failure >30 days prior to index procedure, including a diuretic.
Heart Team determines patient is a recommended candidate for the VDyne System.
Age 18 years or older at time of the index procedure.
Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.

Exclusion Criteria:

VDYNE SYSTEM SUITABILITY

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)
Intolerance to procedural anticoagulation or post-procedural antiplatelet/anticoagulation regimen that cannot be medically managed
Hypersensitivity to nickel or titanium

CLINICAL EXCLUSION CRITERIA (assessed by pre-procedural imaging)
Left Ventricular Ejection Fraction (LVEF) <30%
Severe RV dysfunction as assessed by the Clinical Screening Committee (CSC).
Significant abnormalities of the tricuspid valve and sub-valvular apparatus
Sepsis including active infective endocarditis (IE) (within the last 6 months)
Right ventricular, atrial thrombus, vegetation or mass on tricuspid valve.
Severe tricuspid annular or leaflets calcification
Systolic pulmonary hypertension with systolic pulmonary artery pressure >70 mmHg or pulmonary vascular resistance (PVR) >5 wood units as determined by RHC.
History of rheumatic fever that impacts the native tricuspid valve or surrounding structures.

CONCOMITANT PROCEDURES
Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease (CAD).
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.]
Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound)
Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.
Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.
Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
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.)
Significant valvular heart disease requiring intervention other than the tricuspid valve
Known significant intracardiac shunt [e.g. septal defect), patent foramen ovales (PFOs) without significant shunts are allowed]

COMORBIDITIES
Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure
Severe lung disease [severe chronic obstructive pulmonary disease (COPD) or continuous use of home oxygen or oral steroids]
Acute myocardial infarction (AMI) within 30 days
Significant renal dysfunction (eGFR<30 ml/min/1.73m2) or on dialysis
End-stage liver disease (MELD > 11 and Child-Pugh class C)
Bleeding requiring transfusion within 30 days
Coagulopathy or other clotting disorder that cannot be medically managed
Chronic immunosuppression or other condition that could impair healing response
Any of the following: leukopenia, chronic anemia [Hemoglobin (Hgb) < 9], current thrombocytopenia (platelets <70), history of bleeding diathesis, or coagulopathy
Unwilling to receive blood products GENERAL EXCLUSION CRITERIA
Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically
Life expectancy less than 12 months due to non-cardiac comorbidities
Treatment is not expected to provide benefit (futile)
Current IV Drug user (must be free drug abuse for > 1 year)
Pregnant, lactating or planning pregnancy during the course of the study
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)
Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study
Patient (or legal guardian) unable or unwilling to provide written informed consent before study-specific procedures are conducted
Patient unable or unwilling to comply with study required testing and follow-up visits.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.