Zenith LAA Occlusion System

Launched by AURIGEN MEDICAL LTD · Jul 11, 2023

Keywords

ClinConnect Summary

The Zenith LAA Occlusion System trial is studying a new procedure designed to close off a small part of the heart called the Left Atrial Appendage (LAA) in patients with a type of irregular heartbeat known as non-valvular atrial fibrillation. This closure can help reduce the risk of strokes caused by blood clots that often form in the LAA. The procedure is minimally invasive, which means it can be done with less impact on the body compared to traditional surgery.

To be eligible for this trial, participants should be at least 18 years old, diagnosed with non-valvular atrial fibrillation, and have a certain size of the LAA (between 18 mm and 26 mm). They should also be able to attend follow-up visits and provide consent. However, there are some health conditions that would exclude someone from participating, such as severe heart failure, certain bleeding disorders, or recent heart attacks. If you join the trial, you will undergo the procedure and have regular check-ups to monitor your health and the effectiveness of this new treatment.

Gender

ALL

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%