RF Applications for Residual LAA Leaks (REACT)

Texas Cardiac Arrhythmia Research Foundation

Status: Unknown

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

Treatments: Procedure: Radiofrequency Energy Applications

Study type: Interventional

Funder types: Other

Identifiers

NCT04726943

TCAI_RFLK01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

RF Energy

Experimental group

Description:

RF delivery targeting the atrial side of a significant residual leak in patients with acute and chronic evidence of incomplete percutaneous LAA occlusion

Treatment:

Procedure: Radiofrequency Energy Applications