Ignite Creation Date:
2024-05-06 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05131308
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2021-10-26
Brief Title:
Multimodality Evaluation of LAA Leaks Arising After Incomplete LAAC Insights From the LAA-Leak Registry
Sponsor:
Kansas City Heart Rhythm Research Foundation
Organization:
Kansas City Heart Rhythm Research Foundation
Study Overview
Official Title:
Comparison of the Efficacy of Successful Leak Closure Between Available Leak Closure Methods for Clinically Relevant and Persisting Leaks Arising After Incomplete LAAC Insights From the LAA-Leak Registry
Status:
COMPLETED
Status Verified Date:
2024-04
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:
Closure of peri-device leaks PDL after incomplete LAAC have shown early feasibility however no comparison study of all the leak closure modalities exists Therefore this is an attempt to report the first 3-way observational comparison study to date with results in 160 total patients in 3 arms including detachable embolization coils vascular plugsseptal occluders and Radiofrequency ablation
Detailed Description:
Left Atrial Appendage LAA Closure LAAC is a potent technique of LAA isolation and exclusion for stroke prevention in patients with atrial fibrillation with evidence from the PROTECT-AF and PREVAIL-AF trials including their 5-year follow-up assessments solidifying LAAC as a viable option in these patients with comparable stroke reduction in comparison to oral anticoagulation OAC as well as a reduction in bleeding risk hemorrhagic CVA and mortality However the surge in the multiple methods of LAA exclusion has also brought to attention postprocedural complications specific to LAAC namely peri-device leaks PDL The stroke implication and classification of PDL itself still lacks consensus with an increased thromboembolic TE potential due to PDL seen in patients with LARIAT and surgical ligation procedures yet no statistically significant relationship seen in percutaneous and endocardial LAA closure approaches PDL 5mm has been widely accepted as clinically significant although there remains limited data with no current established guidelines Placement of a septal occluder device such as Amplatzer Vascular Plug Detachable embolization coils Gore Cardioform Septal Occluder CSO WL Gore and Associates Newark DE and radiofrequency ablation RFA have all emerged as options to resolve residual PDL and post-surgicalligation leaks However there exists no head-to-head comparison between these modalities Given their emergence this is a proposed a multi-center observational study to further assess and evaluate these three treatment modalities for their efficacy for leak closure assessment of pre- peri- and post-procedural characteristics after leak closure TE events and bleeding risk and complication rates
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