RF Applications for Residual LAA Leaks

Atrial Fibrillation Clinical Trial

— REACT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04726943
• Other study ID #: TCAI_RFLK01
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2021
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: Andrea Natale, MD
• Phone: 512 544 8186
• Email: dr.natale[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Radiofrequency Energy Applications
RF energy applications to the atrial edge of a leak resulting from incomplete LAA occlusion

Locations

Country	Name	City	State
United States	St. David's Medical Center	Austin	Texas
United States	Kansas City Heart Rhythm Institute	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Success	Complete LAA occlusion or presence of a mild/minimal peri-device leak on FU TEE	1-3 months
Secondary	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