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
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 at the time of screening
• Documented diagnosis of non-valvular AF
• Clinical indication for LAA occlusion
• Willing and able to return to and comply with scheduled follow-up visits and testing, including medical treatment as required by the protocol.
• Willing and able to provide written informed consent
Locations
Other Locations
Australia
The Royal Melbourne Hospital
NOT_YET_RECRUITING
Parkville
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Christchurch Hospital
RECRUITING
Christchurch
Contact Information
Primary
Nuwani Edirisinghe
nuwani.edirisinghe@aurigenmedical.com
+447581155987
Backup
John Thompson
john.thompson@aurigenmedical.com
+353 863525057
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 10
Treatments
Experimental: Zenith LAA Occlusion System
Zenith LAA Occlusion System Implantation
Related Therapeutic Areas
Sponsors
Leads: AuriGen Medical Ltd