Minimally invasive procedure to close the Left Atrial Appendage

Evaluation of the Safety and Performance of the Zenith LAA Occlusion System and Procedure for the Mechanical Closure of the Left Atrial Appendage (LAA)

This study is testing a new, less invasive procedure to close a part of the heart called the Left Atrial Appendage in patients with atrial fibrillation to see if it can help prevent strokes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AuriGen Medical Ltd (Industry-sponsored)
• Locations: 3 sites (Parkville, Victoria and 2 other locations)
• Trial ID: NCT05951101 on ClinicalTrials.gov

What this trial studies

This study aims to demonstrate the safety and effectiveness of the Zenith LAA Occlusion System, a minimally invasive technique designed to occlude the Left Atrial Appendage (LAA) in patients with non-valvular atrial fibrillation. Participants will undergo the procedure to prevent stroke by closing off the LAA, which is a common source of blood clots in these patients. The study will evaluate the performance of the device and the procedure through follow-up visits and testing. Eligible patients must meet specific criteria related to their heart condition and overall health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of non-valvular atrial fibrillation and a clinical indication for LAA occlusion.

Not a fit: Patients with severe heart failure symptoms, known bleeding disorders, or those requiring long-term anticoagulation for other conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could significantly reduce the risk of stroke in patients with atrial fibrillation.

How similar studies have performed: Previous studies have shown promising results with similar LAA occlusion techniques, indicating potential for success in this approach.

Eligibility criteria

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%

Where this trial is running

Parkville, Victoria and 2 other locations

• The Royal Melbourne Hospital — Parkville, Victoria, Australia (Not_yet_recruiting)
• Auckland City Hospital — Auckland, New Zealand (Recruiting)
• Christchurch Hospital — Christchurch, New Zealand (Recruiting)

Study contacts

• Principal investigator: Felix Mahfoud — Internal Medicine and Cardiology, Saarland University Hospital
• Study coordinator: Nuwani Edirisinghe

Conditions Atrial Fibrillation; Left Atrial Appendage; Stroke; LAA Occlusion; LAA closure