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

Completed

Conditions studied: Left Atrail Appendage Closure: Peri-device Leaks

In brief

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.

Key facts

Study ID

NCT05131308

Run by

Kansas City Heart Rhythm Research Foundation

People needed

160

Starts

2015-01-11

Expected to finish

2021-06-08

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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)
• Age greater than 18 years

You may not qualify if…

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

Where it is running

• Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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