Save

Zenith LAA Occlusion System

RECRUITING

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.

Simpliy with AI

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.

Simplify with AI

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%

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-03-28

Primary completion: 2025-01-31

Study completion finish: 2025-12-31

Study type

DEVICE_FEASIBILITY

Phase

Trial ID

NCT05951101

Intervention or treatment

DEVICE: Zenith LAA Occlusion System

Conditions

• Stroke
• Atrial Fibrillation
• Left Atrial Appendage

Condition: Stroke, Atrial Fibrillation and more
DEVICE: Zenith LAA Occlusion System
Parkville, Victoria, Australia
Sponsor: AuriGen Medical Ltd

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

The Royal Melbourne Hospital

Research sites nearby

Select from list below to view details:

The Royal Melbourne Hospital
Parkville, Victoria, Australia

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 Zenith LAA Occlusion System Implantation	DEVICE: Zenith LAA Occlusion System LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Zenith LAA Occlusion System