Ignite Creation Date:
2024-05-06 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03503253
Status:
UNKNOWN
Last Update Posted:
2021-04-06
First Post:
2018-04-11
Brief Title:
Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures
Sponsor:
Texas Cardiac Arrhythmia Research Foundation
Organization:
Texas Cardiac Arrhythmia Research Foundation
Study Overview
Official Title:
Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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:
TREASURE
Brief Summary:
Although the clinical impact of left atrial appendage LAA leaks still requires confirmation the open pouch with residual flow resulting from incomplete LAA closure may promote blood stagnation and thrombus formation and increase the risk of thromboembolic events The main purpose of this trial is to evaluate the safety and efficacy of percutaneous leak closure with detachable vascular coils
Detailed Description:
Therapies locally targeting the LAA via occlusion exclusion or excision have emerged as an alternative and effective approach for stroke prophylaxis in AF patients especially those with OAC contra-indications Despite mounting evidence of their safety and efficacy in comparison with standard oral therapy device-related thrombus and incomplete LAA closure resulting in residual significant leak may occur potentially hindering an effective stroke prevention To date detachable coils have found a wide range of applications for transcatheter occlusionembolization procedures eg cerebral aneurysms pulmonary renal and cerebral arteriovenous malformations patent ductus arteriosus endoleaks The main purpose of this trial is to evaluate the feasibility and efficacy of transcatheter leak closure with detachable coils in patients with evidence of incomplete percutaneousepicardial LAA exclusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None