Clinical trial NCT05951101: Zenith LAA Occlusion System
Official title: Evaluation of the Safety and Performance of the Zenith LAA Occlusion System and Procedure for the Mechanical Closure of the Left Atrial Appendage (LAA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Left Atrial Appendage
Stroke
Keywords: LAA Occlusion
Left Atrial Appendage
Atrial Fibrillation
LAA closure
Lead sponsor: AuriGen Medical Ltd
Sponsor class: INDUSTRY
First posted: 2023-07-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Implantation of Zenith LAA Occlusion System
Primary purpose: DEVICE_FEASIBILITY

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.

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%

Primary outcomes:
measure: Procedural success
timeFrame: 72 hours
measure: Mechanical device closure
timeFrame: 45 days
Secondary outcomes:
measure: Device related thrombus
timeFrame: 45 days and 12 months
measure: SAE
timeFrame: through study completion, an average of 1 year
measure: Stroke
timeFrame: 12 months
measure: Thromboembolism
timeFrame: 12 months
measure: Device closure
timeFrame: 6 months
measure: Device use questionnaire
timeFrame: up to 24 hours
measure: Changes in Quality of Life score according to SF-12 questionnaire
timeFrame: Baseline, 45 days, 6 months and 12 months
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
affiliation: Internal Medicine and Cardiology, Saarland University Hospital
name: Felix Mahfoud
role: PRINCIPAL_INVESTIGATOR
affiliation: Saarland University Hospital
name: Christian Ukena
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Coventry & Warwickshire NHS Trust
name: Sandeep Panikker
role: PRINCIPAL_INVESTIGATOR
References: