NCT05951101

Zenith LAA Occlusion System

Evaluation of the Safety and Performance of the Zenith LAA Occlusion System and Procedure for the Mechanical Closure of the Left Atrial Appendage (LAA)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: AuriGen Medical Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Atrial Fibrillation
• Left Atrial Appendage
• Stroke

Interventions

Type	Name	Description
DEVICE	Zenith LAA Occlusion System	LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm

Timeline

• Start date: 2024-03-28
• Primary completion: 2025-01-31
• Completion: 2025-12-31
• First posted: 2023-07-18
• Last updated: 2024-10-16

Locations

3 sites across 2 countries: Australia, New Zealand