Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099106
Status:
RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-10-19
Brief Title:
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage LAA Closure Device
Sponsor:
Endomatic Ltd
Organization:
Endomatic Ltd
Study Overview
Official Title:
Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage LAA Closure Device in Patients With Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2023-10
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:
None
Brief Summary:
The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage LAA Closure Device in Patients with non-valvular Atrial Fibrillation who are at increased risk for stroke and that cannot take or have a reason to seek an alternative to long-term anticoagulation therapy
Potential patients who are candidates for LAA closure will be screened to confirm that all inclusionexclusion criteria are met with final eligibility confirmation on day of procedure
All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge
Additional follow up time points are scheduled at 45 days 6 months and 12 months post procedure
Potential patients who are candidates for LAA closure will be screened to confirm that all inclusionexclusion criteria are met with final eligibility confirmation on day of procedure
All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge
Additional follow up time points are scheduled at 45 days 6 months and 12 months post procedure
Detailed Description:
None
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