RF Applications for Residual LAA Leaks

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Radiofrequency Energy Applications


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age> 18 years. Presence of a significant LAA leak acutely or at follow-up. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study Exclusion Criteria: Life expectancy < 2 years. pregnant, breastfeeding, or unwilling to practice birth control during participation in the study presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RF Energy<br>RF delivery targeting the atrial side of a significant residual leak in patients with acute and chronic evidence of incomplete percutaneous LAA occlusion | Procedure: Radiofrequency Energy Applications<br>* RF energy applications to the atrial edge of a leak resulting from incomplete LAA occlusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Complete LAA occlusion or presence of a mild/minimal peri-device leak on FU TEE | 1-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-Procedural Success | Complete LAA occlusion or presence of mild/minimal (1-2 mm) residual leak assessed via multiplane color Doppler imaging on TEE/ICE at the end of the procedure | Peri-Procedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, atrial fibrillation, left atrial appendage, prevention, leak, radiofrequency