Atrial Fibrillation, Left Atrial Appendage, Stroke
Conditions
Keywords
LAA Occlusion, Left Atrial Appendage, Atrial Fibrillation, LAA closure
Brief summary
Demonstrate the safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from the left atrium (LA) using a minimally invasive technique. Indication - LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 18 mm and 26 mm
Detailed description
The study objective is to demonstrate the safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from the left atrium (LA) using a minimally invasive technique.
Interventions
DEVICEZenith LAA Occlusion System
LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm
Sponsors
AuriGen Medical Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Implantation of Zenith LAA Occlusion System
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | 72 hours | Acute procedural success is defined as the delivery and release of the Zenith LAA Occlusion System in the target location (LAA) without any device or procedure related serious adverse events until the post-procedure discharge or 72 hours (whichever comes first) |
| Mechanical device closure | 45 days | Mechanical device closure - residual jet around the device ≤5 mm at 45 days by TOE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke | 12 months | Ischemic stroke through 12 months |
| Thromboembolism | 12 months | Systemic thromboembolism through 12 months |
| Device related thrombus | 45 days and 12 months | LAAO device-related thrombus as assessed by TOE at 45 days and by CCTA at 12 months |
| Device use questionnaire | up to 24 hours | Use of the Zenith LAA Occlusion System per Device use questionnaire (Operator) |
| Changes in Quality of Life score according to SF-12 questionnaire | Baseline, 45 days, 6 months and 12 months | Patient-reported health quality at Baseline, 45 days, 6 months, and 12 months |
| Device closure | 6 months | Mechanical device closure - residual jet around the device ≤5 mm at 6 months (if it is not achieved at 45 Days) |
| SAE | through study completion, an average of 1 year | All SAEs device and/or procedure-related post-procedure and to the end of the study |
Countries
Australia, New Zealand
Contacts
Primary ContactNuwani Edirisinghe
Backup ContactJohn Thompson
Outcome results
None listed