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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm
The Royal Melbourne Hospital
Parkville, Victoria, Australia
NOT_YET_RECRUITINGAuckland City Hospital
Auckland, New Zealand
RECRUITINGChristchurch Hospital
Christchurch, New Zealand
RECRUITINGProcedural success
Acute procedural success is defined as the delivery and release of the Zenith LAA Occlusion System in the target location (LAA) without any device or procedure related serious adverse events until the post-procedure discharge or 72 hours (whichever comes first)
Time frame: 72 hours
Mechanical device closure
Mechanical device closure - residual jet around the device ≤5 mm at 45 days by TOE
Time frame: 45 days
Device related thrombus
LAAO device-related thrombus as assessed by TOE at 45 days and by CCTA at 12 months
Time frame: 45 days and 12 months
SAE
All SAEs device and/or procedure-related post-procedure and to the end of the study
Time frame: through study completion, an average of 1 year
Stroke
Ischemic stroke through 12 months
Time frame: 12 months
Thromboembolism
Systemic thromboembolism through 12 months
Time frame: 12 months
Device closure
Mechanical device closure - residual jet around the device ≤5 mm at 6 months (if it is not achieved at 45 Days)
Time frame: 6 months
Device use questionnaire
Use of the Zenith LAA Occlusion System per Device use questionnaire (Operator)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 24 hours
Changes in Quality of Life score according to SF-12 questionnaire
Patient-reported health quality at Baseline, 45 days, 6 months, and 12 months
Time frame: Baseline, 45 days, 6 months and 12 months