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Clinical Trial Summary

Although the clinical impact of residual left atrial appendage (LAA) leaks still requires confirmation, its patency 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 radiofrequency energy applications.


Clinical Trial 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. Radiofrequency energy has been adopted in several settings (e.g., vascular, orthopedic, aesthetic surgery) to achieve thermal-induced tissue retraction. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04726943
Study type Interventional
Source Texas Cardiac Arrhythmia Research Foundation
Contact Andrea Natale, MD
Phone 512 544 8186
Email dr.natale@gmail.com
Status Not yet recruiting
Phase N/A
Start date February 1, 2021
Completion date December 31, 2022

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