Zenith LAA Occlusion System

AuriGen Medical

Status: Enrolling

Conditions: Atrial Fibrillation; Stroke; Left Atrial Appendage

Treatments: Device: Zenith LAA Occlusion System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05951101

CLN002

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Zenith LAA Occlusion System

Experimental group

Description:

Zenith LAA Occlusion System Implantation

Treatment:

Device: Zenith LAA Occlusion System