RF Applications for Residual LAA Leaks

Not Applicable

• Conditions: Left Atrial Appendage Thrombosis; Atrial Fibrillation; Stroke, Ischemic
• Interventions: Procedure: Radiofrequency Energy Applications

• Registration Number: NCT04726943
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-27
• Status Verified: 2021-02
• Study Start: 2021-02-01
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-11
• Primary Completion: 2022-02-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age> 18 years.
2. Presence of a significant LAA leak acutely or at follow-up.
3. 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

1. Life expectancy < 2 years.
2. pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RF Energy	Radiofrequency Energy Applications	RF delivery targeting the atrial side of a significant residual leak in patients with acute and chronic evidence of incomplete percutaneous LAA occlusion

Primary Outcome Measures

Name	Time	Method
Procedural Success	1-3 months	Complete LAA occlusion or presence of a mild/minimal peri-device leak on FU TEE

Secondary Outcome Measures

Name	Time	Method
Peri-Procedural Success	Peri-Procedural	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

Trial Locations

Locations (2)

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

St. David's Medical Center; 🇺🇸 Austin, Texas, United States