RF Applications for Residual LAA Leaks

Status unconfirmed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT04726943

Run by

Texas Cardiac Arrhythmia Research Foundation

People needed

100

Starts

2021-02-01

Expected to finish

2022-12-31

Last updated by the study team

2021-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States
• St. David's Medical Center — Austin, Texas, United States

Full record on ClinicalTrials.gov

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