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
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- 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.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Study for people with Heart Disease
Recruiting Not a phased study
This trial at a glance
Past estimated completion. The registry still lists this trial as open, and the date it gave for finishing has been and gone. Confirm with the official record before you act on it.
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Macquarie University | Macquarie Park | NSW | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
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:
* Has voluntarily decided to participate in this clinical trial and has provided written informed consent
* Adults aged 18 years or older at the time of informed consent
* Has symptoms of TR corresponding to at least NYHA Class II, despite receiving optimal medical therapy for at least 30 days prior to screening
* Meets the criteria at least severe (3+) on the TR grade classification table on echocardiography performed at the screening visit
* Deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist and one cardiac surgeon
* Is able to understand and follow the investigator's instructions and is able to participate for the entire duration of the study
Exclusion Criteria:
* Has blood clots, emboli, masses, or growths in the vascular system of the heart or lungs on an echocardiogram and cardiac CT scan performed at the screening visit
* Uncorrected blood clotting disorders based on hematology tests performed at the screening visit
* Unable to use anticoagulant agents (NOAC ex.Xarelto)
* A history of major bleeding (excluding minor bleeding such as nosebleed that can be hemostasized) treated with anticoagulants at any time prior to participation in this clinical trial
* Severe anemia (hemoglobin less than or equal to 80g/L)
* Has an implanted device such as an implantable cardioverter defibrillator (ICD) or pacemaker
* Has anatomy that, in the opinion of the investigator, is not suitable for implantation of an investigational medical device based on echocardiogram and cardiac CT scan performed at the screening visit
* Requires surgery or interventional procedures (coronary artery bypass graft (CABG) or surgery for atrial septal defect (ASD)) based on an echocardiogram performed at the screening visit
* Platelet count of 50 x 10\^9 per litre of blood or less based on hematology tests performed at the screening visit
* Pulmonary arterial hypertension, defined as pulmonary artery systolic pressure greater than 70mmHg on cardiac catheterization performed at the screening visit, or a pulmonary vascular resistance greater than 3 Wood Units on right heart catheterization
* Left ventricular ejection fraction (LVEF) of less than 20% on echocardiogram performed at the screening visit
* Active gastrointestinal bleeding or a digestive procedure within 90 days prior to screening for this study, and/or those with the potential for gastrointestinal bleeding in the opinion of the investigator
* History of cerebrovascular accident (CVA) or transient ischemic attacks (TIA) within 30 days prior to screening for this clinical trial
* History of myocardial infarction (MI) within 30 days prior to screening for this study
* Active endocarditis requiring antibiotic treatment
* Malignancies or end-stage renal failure requiring hemodialysis and other chronic conditions with a life expectancy of less than one year
* Moderate or severe aortic, pulmonary artery, or mitral stenosis on echocardiogram performed at the screening visit
* Severe or greater mitral valve regurgitation or severe aortic valve regurgitation as determined by echocardiographic grading criteria at the screening visit
* Calcification of the tricuspid valve leaflets affecting the procedure on an echocardiogram performed at the screening visit
* Those who have participated in another clinical trial within 30 days prior to screening for this clinical trial
* Pregnant or breastfeeding, or planning to become pregnant during the clinical trial period
* Participants of childbearing potential who are not using a highly effective method of contraception
* Coexisting condition, which most likely limits the life expectancy to less than one year
* Preexisting pulmonary valve prosthesis or a right ventricle to pulmonary artery (RV-PA) conduit
* Any other clinical findings that, in the opinion of the investigator, are medically inappropriate for this clinical trial
Dates on the record
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: 9 December 2025.
- 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.