Multimodality Evaluation of LAA Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry

Completed

• Conditions: Left Atrail Appendage Closure: Peri-device Leaks
• Interventions: Other: leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA

• Registration Number: NCT05131308
• Lead Sponsor: Kansas City Heart Rhythm Research Foundation

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 plugs/septal 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; W.L. Gore and Associates, Newark DE), and radiofrequency ablation (RFA) have all emerged as options to resolve residual PDL and post-surgical/ligation 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 Timeline

• Study Start: 2015-01-11
• Primary Completion: 2021-03-14
• Study Completion: 2021-06-08
• Status Verified: 2021-10
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-23
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Patients at risk for stroke or thromboembolism that demonstrated any degree of the significant leak on follow up TEE imaging at least 4-6 weeks following either epicardial, endocardial, or surgical LAAC
2. Patients undergoing any form of eccentric or centric/central leak closure with available modalities (detachable embolization coils, vascular plus/septal/ASD occluders, or RF Ablation). Criteria for this was made based on the judgement of the operator, with no specific cutoffs for leak size, follow-up time from LAAC to leak closure, etc)
3. Age greater than 18 years

Exclusion Criteria

1. Patients not undergoing leak closure after incomplete LAAC
2. Patients unable to complete 45 day follow-up imaging for reevaluation of LAA leak
3. Patients unable to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Detachable embolization coils group	leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA	Patients who have an intervention for leak closure with detachable embolization coils
RF Ablation group	leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA	Patients who have an intervention for leak closure with Radio Frequency Ablation (RFA)
Vascular plugs/septal occluders group	leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA	Patients who have an intervention for leak closure with vascular plugs/CSO

Primary Outcome Measures

Name	Time	Method
Size of PDL After Leak Closure Procedure	Immediate postprocedural and 1 year follow-up	Size of leak in mm on TEE after leak closure procedure, immediately at the end of the procedure and at 1 year follow-up

Secondary Outcome Measures

Name	Time	Method
Periprocedural Complications Occurring From Postoperative Day 0 - Day 7	From postoperative day 0 to day 7	Periprocedural complications occurring from Postoperative days 0 - 7, including: device-related thrombus, pericardial effusion/pericardial tamponade requiring intervention and CVA.
Delayed Procedure-related Complications at 1 Year Follow-up	1 year after procedure	Secondary Safety Endpoint: Delayed procedure-related complications at 1 year follow-up including device-related thrombus, pericardial effusion/ pericardial tamponade requiring intervention and CVA.

Trial Locations

Locations (1)

Kansas City Heart Rhythm Institute; 🇺🇸 Overland Park, Kansas, United States