Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures

Status unconfirmed · Not applicable

Conditions studied: Left Atrial Appendage Incomplete Closure

In brief

Although the clinical impact of left atrial appendage (LAA) leaks still requires confirmation, the open pouch with residual flow 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 detachable vascular coils.

Key facts

Study ID

NCT03503253

Run by

Texas Cardiac Arrhythmia Research Foundation

People needed

120

Starts

2018-04-09

Expected to finish

2022-05-01

Last updated by the study team

2021-04-06

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 (moderate/severe following percutaneous occlusions or mild/severe after epicardial exclusions with the LARIAT suture delivery device).
• Less moderate embolic risk (CHA2DS2-VASc ≥2)
• High associated hemorrhagic risk (HASBLED ≥ 3), or absolute contraindication to OAC, or need for prolonged dual antiplatelet therapy, or history of thromboembolic events despite LAA occlusion/exclusion after other potential causes.
• 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

• Texas Cardiac Arrhythmia Institute — Austin, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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