Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04829929
Status:
RECRUITING
Last Update Posted:
2022-12-13
First Post:
2021-03-24
Brief Title:
Evaluation od Safety and Performance of the Omega LAA Left Atrial Appendage Occluder and Omega Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk
Sponsor:
Eclipse Medical Ltd
Organization:
Eclipse Medical Ltd
Study Overview
Official Title:
Prospective Single-arm Study to Assess the Safety and Performance of the Omega Left Atrial Appendage LAA Occluder and Omega Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Omega
Brief Summary:
The purpose of the study is to assess the safety and performance of the Omega LAA Left Atrial Appendage Occluder and Omega Delivery System in LAA Left Atrial Appendage closure for patients with non-valvular atrial fibrillation NVAF and high bleeding risk
Detailed Description:
Omega LAA Left Atrial Appendage Occluder used in combination with the indicated Omega Delivery System is a permanent implant to the left atrial appendage for percutaneous insertion LLA Left Atrial Appendage occlusion appears to be a feasible option for stroke reduction in AF patients at high risk for stroke who are contraindicated for anticoagulation or who suffered a stroke despite OC This study will evaluate safety and performance using a study design which is based on inputs from pre-clinical testing the risk analysis and data available from other LAA Left Atrial Appendage devices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None