Zenith LAA Occlusion System
NARECRUITING
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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Age ≥18 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
- 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])
- 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 (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
- 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
- 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%
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
DEVICE_FEASIBILITY
Phase
- NA
Study ID
NCT05951101
Intervention or treatment
DEVICE: Zenith LAA Occlusion System
Conditions
- Atrial Fibrillation
- Left Atrial Appendage
- Stroke
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
The Royal Melbourne Hospital
Select from list below to view details:
The Royal Melbourne Hospital
Parkville, Victoria, Australia
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Who is running the clinical trial?
AML
AuriGen Medical Ltd
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Zenith LAA Occlusion System
| Device: Zenith LAA Occlusion System |
What is the study measuring?
Primary Outcome
| 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 device or procedure related serious adverse events until the post-procedure discharge or 72 hours (whichever comes first) | 72 hours |
| Mechanical device closure | Mechanical device closure - residual jet around the device ≤5 mm at 45 days by TOE | 45 days |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Device related thrombus | LAAO device-related thrombus as assessed by TOE at 45 days and by CCTA at 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 |
Are you running this trial?If you're a clinic or sponsor, you can claim this study.
References
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