NCT04726943

RF Applications for Residual LAA Leaks

Radiofrequency Energy Applications Targeting Significant Residual Leaks After Left Atrial Appendage Occlusion

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Texas Cardiac Arrhythmia Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Left Atrial Appendage Thrombosis
• Stroke, Ischemic
• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency Energy Applications	RF energy applications to the atrial edge of a leak resulting from incomplete LAA occlusion

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-02-01
• Completion: 2022-12-31
• First posted: 2021-01-27
• Last updated: 2021-02-11

Locations

2 sites across 1 country: United States