Zenith LAA Occlusion System

Study Overview
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Brief Summary
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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 17 mm and 25 mm

Detailed Description
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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.

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

Conditions
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Atrial Fibrillation, Left Atrial Appendage, Stroke

Intervention / Treatment
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* Device: Zenith LAA Occlusion System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 and ≤80 years at the time of screening Documented diagnosis of non-valvular AF Clinical indication for LAA occlusion Willing and able to return to and comply with scheduled follow-up visits and testing, including medical treatment as required by the protocol. Willing and able to provide written informed consent Exclusion Criteria: Within 30 days before the procedure date: Exhibited NYHA class III or IV heart failure symptoms 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: Documented history of myocardial infarction or unstable angina Documented embolic stroke, TIA or suspected neurologic event Chronic renal insufficiency (eGFR ≤15mL/min per 1.73 m2 (CKD-EPI)) or end-stage renal disease Requires long-term oral anticoagulation therapy for a condition other than AF Diagnosed active local or systemic infection, septicaemia, active pericarditis, or fever of unknown origin Known acquired or inherited propensity for forming blood clots (e.g., malignancy and factor V Leiden mutation) established by prior objective testing Contraindication to the standard of care post-implantation antithrombotic medication regime (e.g., dual antiplatelet therapy (DAPT)/direct oral anticoagulant (DOAC) Rheumatic heart disease Implanted mechanical valve prosthesis Documented carotid disease, defined as greater than 70% stenosis without symptoms or greater than 50% stenosis with symptoms Body mass index greater than 40 kg/m2 Patient is pregnant or breastfeeding or plans/desires to get pregnant within the next 12 months post-procedure 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 Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the study Any other criteria, medical illness, or comorbidity which would make the subject unsuitable to participate in this study as determined by the clinical site principal investigator Patients with known allergy or sensitivity to nitinol (nickel and titanium) or any of the other materials in the Zenith LAA Occlusion System Implant Life expectancy of less than 1 year 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 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: 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 Patients where CCTA analysis suggests that the Zenith LAA Occlusion System may not be suitable Intracardiac thrombus diagnosed by CCTA or echocardiography Previous occlusion/ligation of the LAA (by any surgical or percutaneous method) 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 Documented Left Ventricular Ejection Fraction (LVEF) <30%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Implantation of Zenith LAA Occlusion System
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zenith LAA Occlusion System<br>Zenith LAA Occlusion System Implantation | Device: Zenith LAA Occlusion System<br>* LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Acute procedural success is defined as the delivery and release of the Zenith LAA Occlusion System in the target location (LAA) without any serious adverse events until the post-procedure discharge or 72 hours (whichever comes first) | 72 hours | 
| Device success | Acute device success is defined as procedural success without any device failure/malfunction or device deficiencies at the end of the procedure | End of procedure | 
| Mechanical device closure | Mechanical device closure - residual jet around the device ≤5 mm at 45 days by TOE | 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device related thrombus | LAAO device-related thrombus as assessed by TOE at 45 days and 12 months | 45 days and 12 months | 
| SAE | All SAEs device and/or procedure-related post-procedure and to the end of the study | through study completion, an average of 1 year | 
| Stroke | Ischemic stroke through 12 months | 12 months | 
| Thromboembolism | Systemic thromboembolism through 12 months | 12 months | 
| Device closure | Mechanical device closure - residual jet around the device ≤5 mm at 6 months (if it is not achieved at 45 Days) | 6 months | 
| Device use questionnaire | Use of the Zenith LAA Occlusion System per Device use questionnaire (Operator) | up to 24 hours | 
| Changes in Quality of Life score according to SF-12 questionnaire | Patient-reported health quality at Baseline, 45 days, 6 months, and 12 months | Baseline, 45 days, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LAA Occlusion, Left Atrial Appendage, Atrial Fibrillation, LAA closure