Zenith LAA Occlusion System

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation; Left Atrial Appendage; Stroke

• Registration Number: NCT05951101
• Lead Sponsor: AuriGen Medical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-6-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age =18 and =80 years at the time of screening<br><br> 2. Documented diagnosis of non-valvular AF<br><br> 3. Clinical indication for LAA occlusion<br><br> 4. Willing and able to return to and comply with scheduled follow-up visits and<br> testing, including medical treatment as required by the protocol.<br><br> 5. Willing and able to provide written informed consent<br><br>Exclusion Criteria:<br><br>Within 30 days before the procedure date:<br><br> 1. Exhibited NYHA class III or IV heart failure symptoms<br><br> 2. Known bleeding disorders (such as bleeding diathesis, thrombocytopenia [platelet<br> count <100 X 109/L], severe anaemia [haemoglobin of <8 g/dL], or INR >2<br> [spontaneous])<br><br> Within 90 days before the procedure date:<br><br> 3. Documented history of myocardial infarction or unstable angina<br><br> 4. Documented embolic stroke, TIA or suspected neurologic event<br><br> 5. Chronic renal insufficiency (eGFR =15mL/min per 1.73 m2 (CKD-EPI)) or end-stage<br> renal disease<br><br> 6. Requires long-term oral anticoagulation therapy for a condition other than AF<br><br> 7. Diagnosed active local or systemic infection, septicaemia, active pericarditis, or<br> fever of unknown origin<br><br> 8. Known acquired or inherited propensity for forming blood clots (e.g., malignancy and<br> factor V Leiden mutation) established by prior objective testing<br><br> 9. Contraindication to the standard of care post-implantation antithrombotic medication<br> regime (e.g., dual antiplatelet therapy (DAPT)/direct oral anticoagulant (DOAC)<br><br> 10. Rheumatic heart disease<br><br> 11. Implanted mechanical valve prosthesis<br><br> 12. Documented carotid disease, defined as greater than 70% stenosis without symptoms or<br> greater than 50% stenosis with symptoms<br><br> 13. Body mass index greater than 40 kg/m2<br><br> 14. Patient is pregnant or breastfeeding or plans/desires to get pregnant within the<br> next 12 months post-procedure<br><br> 15. Current or planned enrolment in an investigation or study of an investigational<br> device or investigational drug that would interfere with this study and the required<br> follow-up<br><br> 16. Mental impairment or other psychiatric conditions which may not allow the patient to<br> understand the nature, significance, and scope of the study<br><br> 17. Any other criteria (including physical and mental health), medical illness, or<br> comorbidity which would make the subject unsuitable to participate in this study as<br> determined by the clinical site principal investigator<br><br> 18. Patients with known allergy or sensitivity to nitinol (nickel and titanium) or any<br> of the other materials in the Zenith LAA Occlusion System Implant<br><br> 19. Life expectancy of less than 1 year<br><br> 20. Inability, unwillingness, or contraindication to undergo Trans-Oesophageal and/or<br> Trans-Thoracic Echocardiogram (TOE/TTE) or Cardiac Computed Tomography Angiography<br> (CCTA) imaging or any catheterisation procedures<br><br> 21. Any anatomical condition that precludes the patient from undergoing LAA occlusion<br> with the AuriGen Zenith LAA Occlusion System implant procedure, as determined by the<br> principal investigator<br><br> Imaging Exclusion Criteria:<br><br> 22. Patients with a maximal ostial left atrial appendage diameter >25 mm or <17 mm by<br> pre-procedural ECG-gated CT scan, to fit the Zenith LAA Occlusion System<br><br> 23. Patients where CCTA analysis suggests that the Zenith LAA Occlusion System may not<br> be suitable<br><br> 24. Intracardiac thrombus diagnosed by CCTA or echocardiography<br><br> 25. Previous occlusion/ligation of the LAA (by any surgical or percutaneous method)<br><br> 26. Documented presence of implanted closure devices (e.g. Atrial septal defect (ASD),<br> Patent foramen ovale (PFO) or Ventricular septal defect (VSD) device) for congenital<br> defect treatment<br><br> 27. Documented Left Ventricular Ejection Fraction (LVEF) <30%

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedural success;Mechanical device closure

Secondary Outcome Measures

Name	Time	Method
Stroke;Thromboembolism;Device closure;Device use questionnaire;Changes in Quality of Life score according to SF-12 questionnaire;Device related thrombus;SAE