Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-03-28
2025-12-31
Brief Summary
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Indication - LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 18 mm and 26 mm
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Zenith LAA Occlusion System
Zenith LAA Occlusion System Implantation
Zenith LAA Occlusion System
LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm
Interventions
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Zenith LAA Occlusion System
LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm
Eligibility Criteria
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Inclusion Criteria
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
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
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%
18 Years
ALL
No
Sponsors
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AuriGen Medical Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Felix Mahfoud
Role: PRINCIPAL_INVESTIGATOR
Internal Medicine and Cardiology, Saarland University Hospital
Christian Ukena
Role: PRINCIPAL_INVESTIGATOR
Saarland University Hospital
Sandeep Panikker
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Coventry & Warwickshire NHS Trust
Locations
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The Royal Melbourne Hospital
Parkville, Victoria, Australia
Auckland City Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Countries
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Central Contacts
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Facility Contacts
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Matthew Brooks
Role: backup
Will Wilson
Role: backup
Matthew O'Connor, MA MB BChir FRACP
Role: backup
Andrew Martin
Role: backup
Philip Adamson, MBChB PhD MPH FRACP FCSANZ
Role: backup
Richard Troughton
Role: backup
Ian Crozier
Role: backup
Geoffrey Clare
Role: backup
Other Identifiers
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CLN002
Identifier Type: -
Identifier Source: org_study_id
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