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
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 |
|---|---|---|---|
| The Royal Melbourne Hospital | Parkville | VIC | Not yet 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:
1. Age ≥18 at the time of screening
2. Documented diagnosis of non-valvular AF
3. Clinical indication for LAA occlusion
4. Willing and able to return to and comply with scheduled follow-up visits and testing, including medical treatment as required by the protocol.
5. Willing and able to provide written informed consent
Exclusion Criteria:
Within 30 days before the procedure date:
1. Exhibited NYHA class III or IV heart failure symptoms
2. Known bleeding disorders (such as bleeding diathesis, thrombocytopenia \[platelet count \<100 X 109/L\], severe anaemia \[haemoglobin of \<8 g/dL\], or INR \>2 \[spontaneous\])
Within 90 days before the procedure date:
3. Documented history of myocardial infarction or unstable angina
4. Documented embolic stroke, TIA or suspected neurologic event
5. Chronic renal insufficiency (eGFR ≤15mL/min per 1.73 m2 (CKD-EPI)) or end-stage renal disease
6. Requires long-term oral anticoagulation therapy for a condition other than AF
7. Diagnosed active local or systemic infection, septicaemia, active pericarditis, or fever of unknown origin
8. Known acquired or inherited propensity for forming blood clots (e.g., malignancy and factor V Leiden mutation) established by prior objective testing
9. Contraindication to the standard of care post-implantation antithrombotic medication regime (e.g., dual antiplatelet therapy (DAPT)/direct oral anticoagulant (DOAC)
10. Rheumatic heart disease
11. Implanted mechanical valve prosthesis
12. Documented carotid disease, defined as greater than 70% stenosis without symptoms or greater than 50% stenosis with symptoms
13. Body mass index greater than 40 kg/m2
14. Patient is pregnant or breastfeeding or plans/desires to get pregnant within the next 12 months post-procedure
15. Current or planned enrolment in an investigation or study of an investigational device or investigational drug that would interfere with this study and the required follow-up
16. Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the study
17. Any other criteria (including physical and mental health), medical illness, or comorbidity which would make the subject unsuitable to participate in this study as determined by the clinical site principal investigator
18. Patients with known allergy or sensitivity to nitinol (nickel and titanium) or any of the other materials in the Zenith LAA Occlusion System Implant
19. Life expectancy of less than 1 year
20. Inability, unwillingness, or contraindication to undergo Trans-Oesophageal and/or Trans-Thoracic Echocardiogram (TOE/TTE) or Cardiac Computed Tomography Angiography (CCTA) imaging or any catheterisation procedures
21. Any anatomical condition that precludes the patient from undergoing LAA occlusion with the AuriGen Zenith LAA Occlusion System implant procedure, as determined by the principal investigator
Imaging Exclusion Criteria:
22. Patients with a maximal ostial left atrial appendage diameter \>25 mm or \<17 mm by pre-procedural ECG-gated CT scan, to fit the Zenith LAA Occlusion System
23. Patients where CCTA analysis suggests that the Zenith LAA Occlusion System may not be suitable
24. Intracardiac thrombus diagnosed by CCTA or echocardiography
25. Previous occlusion/ligation of the LAA (by any surgical or percutaneous method)
26. Documented presence of implanted closure devices (e.g. Atrial septal defect (ASD), Patent foramen ovale (PFO) or Ventricular septal defect (VSD) device) for congenital defect treatment
27. Documented Left Ventricular Ejection Fraction (LVEF) \<30%
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: 16 October 2024.
- 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.