RF Applications for Residual LAA Leaks

ClinicalTrials.gov ID

NCT04726943

Lead Sponsor

Texas Cardiac Arrhythmia Research FoundationOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

100Estimated

Last Update Posted

Feb 11, 2021Actual

Start Date

Feb 1, 2021Estimated

Primary Completion Date

Feb 1, 2022Estimated

Completion Date

Dec 31, 2022Estimated

Official Title

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

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.

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

• Radiofrequency Energy Applications

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Texas Cardiac Arrhythmia Research FoundationOTHER

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