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Zenith LAA Occlusion System
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-03-28
Primary completion: 2025-01-31
Study completion finish: 2025-12-31
Study type
DEVICE_FEASIBILITY
Phase
NA
Trial ID
NCT05951101
Intervention or treatment
DEVICE: Zenith LAA Occlusion System
Conditions
- • Stroke
- • Atrial Fibrillation
- • Left Atrial Appendage
Find a site
Closest Location:
The Royal Melbourne Hospital
Research sites nearby
Select from list below to view details:
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Zenith LAA Occlusion System
| DEVICE: Zenith LAA Occlusion System
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Procedural 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) | 72 hours |
Mechanical device closure | Mechanical device closure - residual jet around the device ≤5 mm at 45 days by TOE | 45 days |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Device related thrombus | LAAO device-related thrombus as assessed by TOE at 45 days and by CCTA at 12 months | 45 days and 12 months |
SAE | All SAEs device and/or procedure-related post-procedure and to the end of the study | through study completion, an average of 1 year |
Stroke | Ischemic stroke through 12 months | 12 months |
Thromboembolism | Systemic thromboembolism through 12 months | 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) | 6 months |
Device use questionnaire | Use of the Zenith LAA Occlusion System per Device use questionnaire (Operator) | 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 | Baseline, 45 days, 6 months and 12 months |
Frequently Asked Questions
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