Evaluation of the Safety and Performance of the Zenith LAA Occlusion System and Procedure for the Mechanical Closure of the Left Atrial Appendage (LAA).
Left Atrial Appendage (LAA) closure in patients with non-valvular atrial fibrillation and a maximum LAA ostium width and/or deployed occluder implant diameter between 18 and 26 mm
Sponsor
AuriGen Medical Ltd., Ireland
Study objectives
Safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from LA using a minimally invasive technique.
Primary endpoints
Safety:
- 1. Acute procedural success is defined as the delivery and release of the Zenith LAA Occlusion System in the target location (LAA) without any serious adverse events until the post-procedure discharge or 72 hours (whichever comes first)
- 2. Acute device success is defined as procedural success without any device failure/malfunction or device deficiencies at the end of the procedure
Performance:
- 1. Mechanical device closure - residual jet around the device ≤5 mm at 45 days by TOE
CERC Services
- Transoesophageal Echocardiography analysis
Countries
New Zealand
Number of investigational sites
5
