Actively Recruiting
Zenith LAA Occlusion System
Led by AuriGen Medical Ltd · Updated on 2024-10-16
10
Participants Needed
3
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Zenith LAA Occlusion System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of screening
- Documented diagnosis of non-valvular atrial fibrillation
- Clinical indication for Left Atrial Appendage occlusion
- Willing and able to return to and comply with scheduled follow-up visits and testing, including required medical treatment
- Willing and able to provide written informed consent
You will not qualify if you...
- NYHA class III or IV heart failure symptoms within 30 days before the procedure
- Known bleeding disorders such as bleeding diathesis, thrombocytopenia (platelet count <100 x 10^9/L), severe anemia (hemoglobin <8 g/dL), or spontaneous INR >2 within 30 days before the procedure
- History of myocardial infarction or unstable angina within 90 days before the procedure
- Documented embolic stroke, transient ischemic attack, or suspected neurologic event within 90 days before the procedure
- Chronic renal insufficiency (eGFR ≤15 mL/min per 1.73 m²) or end-stage renal disease within 90 days before the procedure
- Requirement for long-term oral anticoagulation therapy for conditions other than atrial fibrillation
- Diagnosed active local or systemic infection, septicemia, active pericarditis, or fever of unknown origin within 90 days before the procedure
- Known acquired or inherited propensity for forming blood clots, such as malignancy or factor V Leiden mutation
- Contraindication to standard post-implantation antithrombotic medication (e.g., dual antiplatelet therapy or direct oral anticoagulants)
- Rheumatic heart disease
- Implanted mechanical valve prosthesis
- Documented carotid disease with >70% stenosis without symptoms or >50% stenosis with symptoms
- Body mass index greater than 40 kg/m²
- Pregnancy, breastfeeding, or plans to become pregnant within 12 months after the procedure
- Current or planned participation in another investigational device or drug study that interferes with this study
- Mental impairment or psychiatric conditions preventing understanding of the study
- Any other medical or mental condition making participation unsuitable as determined by the investigator
- Known allergy or sensitivity to nitinol (nickel and titanium) or other materials in the device
- Life expectancy less than 1 year
- Inability or contraindication to undergo Trans-Oesophageal and/or Trans-Thoracic Echocardiogram or Cardiac Computed Tomography Angiography or catheterization procedures
- Anatomical conditions preventing use of the Zenith LAA Occlusion System as determined by the investigator
- Maximal ostial left atrial appendage diameter >25 mm or <17 mm by ECG-gated CT scan
- CCTA analysis indicating unsuitability for the device
- Presence of intracardiac thrombus diagnosed by imaging
- Previous occlusion or ligation of the Left Atrial Appendage
- Presence of implanted closure devices for congenital defects (ASD, PFO, VSD)
- Left Ventricular Ejection Fraction (LVEF) less than 30%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Not Yet Recruiting
2
Auckland City Hospital
Auckland, New Zealand
Actively Recruiting
3
Christchurch Hospital
Christchurch, New Zealand
Actively Recruiting
Research Team
N
Nuwani Edirisinghe
CONTACT
J
John Thompson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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